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San Diego, California, JOB SUMMARY Under the direction of the Director of Post Market Quality, the Sr. Quality Manager Complaint Investigations leads a team of Quality Engineers and Technicians and is responsible for the development, implementation and maintenance of processes associated with complaint investigations pertaining to the Alaris® infusion pumps. This individual will be responsible for the integrity of the complaint investigations and ensure that investigation conclusions are clear, supported, robust and compliant. This individual will establish best practices in complaint investigation processes for a large volume of complaints and associated root cause determination protocols and testing methodologies. Additionally, this individual must have strong analytical skills and effective communication across all levels of the company and demonstrate strong teamwork and collaboration across several functional areas to drive continuous product improvements.   Job Description DUTIES AND RESPONSIBILITIES Designs, implements, and maintains complaint investigation processes and procedures, including writing requirements and process documentation. Ability to solve complex problems by developing novel failure investigation test methodologies and associated processes and training materials. Serve as a Subject Matter Expert for complaint investigations which includes both internal functional support and external customer support with respect to complaint investigation findings and associated improvements initiatives. Provide complaint investigation and quality engineering expertise and consultation to significant / complex projects. Ensure timely completion of complaint failure investigations and communicate with management and team members as required to ensure appropriate actions are taken to maintain/restore timeliness goals. Ensure all complaint investigations failures have been adequately risk-assessed and initiate and champion new risk assessments as required. Performed audit remediation of the complaint process as part of on-going FDA compliance activities and 483 corrective actions. Own and/or lead investigations and root cause analysis efforts for Corrective and Preventive Actions (CAPAs) when necessary.  Develop, compile and present complaint investigation process summary metrics to Senior and Executive Management, as necessary. Communicates complaint investigation findings to appropriate personnel and escalates to Senior Management on critical issues as necessary. Contribute to product safety, product quality, and customer satisfaction related decisions (both data-based and risk-assessment-based decisions). Ensure complaint investigation documentation and records are complete and in compliance with regulatory requirements. Participate and support internal, external audits and inspections as needed. Performs other related duties and activities as required: project management, resource assessments, presentation creation and strategic planning. Manages and coordinates the complaint investigation team and associates who exercise responsibility for results in terms of investigation accuracy, completion time, and documentation.  Areas of responsibility include Customer Complaint Investigations and associated complaint investigation metrics. Implements processes for handling a large volume of complaints incoming through global locations, depot and field service records. Identifies and implements efficiency and compliance improvements to the complaint investigation process. Ability to link CAPA or other failure investigations to complaint records. Participates in external regulatory inspections. Ensures that pre and post-inspection activities are completed including record review, training, logistics, etc. Prepares responses to audit nonconformities for review by senior management with respect to complaint investigations. Assures all relevant complaints are escalated to Risk Analysis and/or Situational Analysis Provide guidance and mentoring to complaint investigation team to ensure investigation best-practices are implemented and utilized during complaint investigations of Alaris® infusion pumps     MINIMUM QUALIFICATIONS   Experience and Education BS/BA in Engineering discipline or related field. Experience leading and building a strong Failure Investigation or CAPA team. Professional certification is an advantage (e.g., CQE, CRE, Lean Six Sigma, Six Sigma Black Belt, etc) Minimum of 10 years of progressive experience leading failure investigation teams and demonstrated history of effective root cause determination in complex electro-mechanical, software-driven medical devices in a high-volume manufacturing environment. Must possess solid background of establishing new failure investigation processes, test protocols, and procedures.   Knowledge and Skills Effective oral and written communication skills targeted at all levels within the company.  Experience in supervision of or in working with a product/component failure analysis lab. Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment. Demonstrated ability to manage, develop and mentor exempt and non-exempt level personnel both inside and outside the department reporting structure. Demonstrated knowledge of implementing new test methods and associated validation strategy and documentation. Project management utilizing analytical, technical, and problem-solving skills.  Able to perform multiple complex tasks/projects and prioritize workloads and activities for large volumes of complaints. Strong organizational skills and demonstrated ability to meet tight deadlines in an environment of competing priorities. Excellent computer skills (Including but not limited to: Microsoft Office, Minitab, SAP, TrackWise) Extensive knowledge of FDA Quality Systems Regulations 21 CFR Part 820, Medical Device Reporting 21 CFR 803, Report of Corrections and Removals 21 CFR 806, ISO 13485 Quality Management Systems Medical Devices, ISO 14971 Risk Management. International Regulations for Medical Devices e.g. but not limited to: EU Medical Device Regulation (MDR), Canada SOR/98-282 Medical Device Regulations. Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously. Demonstrated ability to successfully interact with regulatory authorities at inspections regarding failure investigation activities (prior experiencing as failure investigation SME during inspections is a must).     Becton, Dickinson and Company is an Equal  Opportunity/Affirmative  Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Durango, Colorado, At  La Plata Electric Association , our mission is to provide our members safe, reliable electricity at the lowest reasonable cost while being environmentally responsible.  We are shaping the future by building trustworthy community partnerships as an innovative, forward-thinking industry leader, delivering excellence in our member-owned cooperative. LPEA is seeking a safety minded, highly motivated, detail-oriented, analytical, innovative and people-focused individual to join our dynamic People and Culture  team. The Business Continuity and Safety Specialist will be responsible for developing and implementing a best in class safety solutions for the cooperative. Summary The Safety and Business Continuity Specialist is expected to promote and support LPEA’s mission and vision, strategic goals and initiatives, the Code of Excellence, and LPEA’s Leadership Principles. They will collaborate across the organization to promote a culture of safety and to develop, implement, and evaluate LPEA’s programs to reduce occupational accidents and illnesses in compliance with applicable laws and regulations.  They will also develop and administer LPEA’s Emergency Preparedness and Business Continuity Plan. Essential Job Functions Initiate LPEA safety and training programs and ensures that a comprehensive and effective safety program is functioning on a continual basis. Plan and direct surveys and research studies to assure effective program operation and to recommend improvements to establish or modify standards with efforts directed at maintaining a zero accident/incident rate. Develop, manage, and train employees on Emergency Preparedness and Business Continuity Plan in partnership with relevant internal and external stakeholders. Assign and/or lead on-site inspections, audits, noise level surveys and job observations ensuring corrective actions are taken to reduce or eliminate immediate hazards. Administrate, approve, and maintain PCB control program, DOT Commercial Drivers program, all employee driver records, DOT drug testing, MSDS program, and stay current on all OSHA requirements, providing updates as needed. Prepare and maintain Workers’ Compensation records between employees injured on the job and Federated Rural Electric Insurance Exchange. Interview and coordinate the investigation of accidents with supervisors and employees to determine causes and devise preventive measures. Compile and analyze accident and safety data and provide recommendations for developing and implementing remedial measures. Complete all required reports and forms and provides information to CEO. Inspect and rate unsafe conditions, according to factors such as severity of potential injury, likelihood of recurrence, employer's accident record, and evidence of voluntary compliance. Provide advice and instruct employees, supervisors, managers, and the CEO on the proper use of all safety equipment and how to avoid, correct, and remedy safety violations and/or incidents. Provide technical safety support on high-voltage electrical construction standards and work processes. Write new safety order proposal designed to protect workers from work methods, processes, or other hazards not previously covered, using knowledge of safety-engineering practices, available protective devices, safety testing, and occupational safety and health standards. Review and ensure LPEA meets all NRECA requirements. Interpret and clarify Federal, State, and/or Municipal Laws and regulations to advise employer of legal requirements. Provide advice and source data to prepare applications to regulatory bodies for changes in complaints or services. Recommend changes in legislation and administrative procedures to reflect technological and ecological changes and public sentiment. Review rulings to determine changes in legal stipulations and probable effects on company activities. Testify in legal proceedings and prepare documents for use of company witnesses summoned to testify. Act as liaison to, and work directly with, stakeholders who share a common responsibility to resolve problems for employee and organizational safety (i.e., management, staff employees, members, Federal, State, and Local Agency Representatives). Conduct informal meetings among various educational, civic, and industrial groups to promote general safety concepts. Prepare and review extensive monthly, quarterly, and annual summary data. Complete all required reporting. Safeguard facilities, control access to buildings and grounds, and provide personal safety to all involved. Assist in the development of departmental budget, goals, and objectives. Performs other duties as assigned. Minimum Qualifications Knowledge of: Safety regulations and hazards inherent to the electric utility industry. Specific knowledge of applicable state and federal safety standards for electrical workers. Electrical construction standards and work processes. Accident reporting and investigation techniques. Industrial hygiene practices. Project management. Contracting processes. Business concepts and theories. Coaching and consulting techniques. Computer applications including word processing, spreadsheets, and data bases. Disaster preparedness Ability to: Interpret Federal, State, and local codes, standards, regulations and understand construction standards and processes with an emphasis on high voltage electrical requirements. Interpret cooperative directives and procedures. Communicate effectively with all levels of the organization and outside agencies. Develop/interpret/manage safety contracts. Conduct accident investigations. Work independently and use discretionary judgment. Serve as technical lead or advisor. Use personal computer and associated software. Analyze safety hazards, statistics, and reports. Conduct respirator fit tests. Use noise level analysis equipment. Work with confidential information. Train and instruct employees and the public. Proficient in First Aid and CPR. Work effectively as a team member. Required to be on call 24-hours a day for emergencies Experience/Education Bachelor's degree (B. A.) from four-year college or university; or four years related experience and/or training; or equivalent combination of education and experience, such as Journeyman Lineman Experience, with at least 8 years of experience in the electric utility industry. License/Certification Valid Colorado Driver’s License. Must become a Certified Loss Control Professional within 24 months by successfully passing the NRECA Loss Control Internship Must successfully complete the OSHA #501 and #503 30-hour courses within specified time.  Working Conditions Duties are performed usually in an office type environment. Investigate safety incidents in all weather and site conditions. Conduct safety site visits with personnel. Required to travel frequently between District facilities and construction/accident sites where incumbent may be exposed to electrical hazards, chemicals, hazardous waste materials and weather extremes to perform job site functions. Must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Benefits Medical Insurance Dental & Vision Insurance Paid Vacation Personal Leave Sick Time 401(k) Health Club Reimbursement Education Assistance

Sunnyvale, California, Silicon Valley Clean Energy is seeking a Senior Data Engineer who works under the direction of the Director for Decarbonization & Grid Innovation to lead an organization-wide data strategy, and the design, implementation and management of an optimized and reliable overarching data architecture for SVCE’s business functions to support achieving our decarbonization mission.    The position will be responsible to:  Design, implement and manage an optimized and reliable overarching data architecture to support SVCE’s business and mission. Develop and maintain the infrastructure required for extraction, transformation, and loading of data from a wide variety of data sources (ETL). Identify, design, and implement internal process improvements, including automating manual processes, optimizing data delivery, and re-designing infrastructure for greater scalability. Design and implement best practices for data storage, versioning, querying, as well as managing relevant Build processes supporting data transformation, data structures, metadata, dependency, and workload Collaborate across the organization and with external partners to aggregate additional relevant data sets to support business functions. Design and develop data analytics dashboards and visualization tools. Collaborate with internal and external stakeholders to understand business and policy challenges, goals and objectives and translate them into data analytics use Support data requests with key Silicon Valley stakeholders such as research institutions, start-ups, high-tech, students and the community Qualifications for Senior Data Engineer Any combination of experience and training that would likely provide the required knowledge and abilities is qualifying.   Education: A Bachelor’s Degree from an accredited university or college in science, technology, engineering, mathematics, or a related, quantitative field. A Master’s Degree in the aforementioned fields can substitute for up to one year of the required experience. A Doctoral Degree in the aforementioned fields can substitute for up to three years of the required experience. Experience: Six (6) years of progressively responsible experience as a data engineer at an electric utility, cleantech company, software company, or similar organization Applicants must submit a cover letter outlining key qualifications and reasons for your interest, a current resume including education and 5 years of previous employment history, and a completed copy of the SVCE job application, available at http://www.svcleanenergy.org/jobs . Please email these documents and any questions to: hr@svcleanenergy.org by 5 PM on July 31, 2020 .   Competitive benefits

INFORMS Journal on Computing, Ahead of Print.

INFORMS Journal on Computing, Ahead of Print.

INFORMS Journal on Computing, Ahead of Print.

INFORMS Journal on Computing, Ahead of Print.

INFORMS Journal on Computing, Ahead of Print.