- Support Quality and IT for the creation and implementation of an electronic, quality system and collaborate with the eQMS vendor to facilitate testing, validation, troubleshooting, and system expansion projects based on application needs and growth.
- Lead and administer the workflow for Engineering Change Orders (ECOs), documents and records management, learning management system, and other electronic process workflow in the eQMS.
- Support document control activities by reviewing and completing documentation, including Device History Records (DHR), engineering change orders, log sheets, and databases.
- Partner with Subject Matter Experts (SME), process owners, and human resource department to develop, deliver, and manage quality system training content into the eQMS learning management system, including reporting KPI training metrics to management.
- Lead or support the management of external standards and regulatory intelligence processes.
- Working with cross-functional teams to qualify new suppliers, monitor supplier performance, assess supplier change notifications, risk assessments, material related investigations, supplier process verification/qualification, and supplier corrective actions requests (SCARs).
- Oversee and manage supplier evaluation/re-evaluation, initiating supplier score cards, provide feedback to suppliers as necessary and drive supplier performance levels to support business needs/objectives.
- Support in monitoring product quality, ensuring compliance with standards, identifying issues, and recommending solutions.
- Lead and/or support internal and external audits, including supplier audits.
- Support manufacturing process development and qualification for new product commercialization and product changes.
- Investigate and analyze customer complaints and field failures, including medical device adverse event reportability determination. Participate in failure analysis and define and implement necessary solutions to prevent recurrence based on the outcome of the investigation.
- Review and analyze complaints data to determine trends and prepare reports based on the analyzed information including collaboration with QC/Engineering department to complete the failure investigation reports promptly and consistently. Work with vendors to resolve issues, close non-conforming material reports in a timely manner, and ensure compliance with internal procedures.
- Lead/support the CAPA process as an assigned owner or as a member of the investigation team to identify root cause, evaluate the overall risk to product and Quality System and identify appropriate corrective and preventative action plans.
- Support company goals and objectives, policies and procedures, FDA Quality System Regulation-21 CFR, part 820, EU MDD/MDR and applicable global standards and regulations.
- Performs other duties as assigned by Supervisor.
- Proficient in product life cycle management systems (PLM)/electronic QMS (e.g., Arena, Agile, etc.) and able to work cross-functionally to develop, implement and maintain the systems.
- Working experience within the medical device industry, specifically 21 CFR 820, ISO 13485:2016, and EU MDD/MDR.
- At least 2-5 years of medical device experience, with exposure to Change Control, CAPA, Supplier Controls, NCMRs, and/or Complaint Handling.
- Exposure to Design Control and Risk Management per ISO 14971 a plus.
- Demonstrated use of Quality tools/methodologies including Root Cause Analysis, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, and Statistical Analysis.
- Excellent written and verbal communication skills, including time management skills to handle multiple tasks in a fast-paced, results-oriented environment.
- Experience in the development and implementation of Product Life Cycle Management for the management of data and processes used in design, engineering, and manufacturing of products across its entire lifecycle and the supply chain is a plus.
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Quality Engineer I/II - San Leandro, United States - Medical Instrument Development Laboratories, Inc.
Description
POSITION SUMMARY:
You are a self-starting, detail-oriented, quick-learning, creative, and analytical individual. You will provide day-to-day quality engineering support and development needs for MID Labs electronic Quality Management Systems (eQMS). As an integral member of the Quality team, this position partners with Operations, Materials, and R&D to create and maintain QMS processes to meet manufacturing, product development, and business objectives along with managing the effectiveness and standardization of the QMS across the organization. This includes system/procedural improvements, data/process analysis, metrics reporting, troubleshooting problems, and maintaining a compliant and secure system environment. Other duties include supporting supplier development activities, nonconforming material (NCMR) processes, engineering change order processes, deviations, complaint handling, corrective and preventive action processes, including batch records review.
ESSENTIAL FUNCTIONS:
REQUIRED EXPERIENCE:
EDUCATION:
BS in an Engineering discipline or equivalent.
ASQ Certification (CQE, CQA, CSQP, etc.) highly desirable.
ISO13485:2016 Lead Auditor certification highly desirable.
