Medical Device Quality Engineer

7 days ago

Santa Rosa, United States Kelly Science, Engineering, Technology & Telecom Full time

Kelly Science, Engineering, Technology and Telecom a managed solution provider and business unit of Kelly Services, is currently seeking a Medical Device Quality Assurance Engineer for a long-term engagement at one of our Global Medical Device Manufacturing clients located in Santa Rosa, CA.

Our client is a clinical-stage medical device company advancing transseptal left atrial appendage (LAA) closure.The growing incidence of atrial fibrillation and medical device developments have rapidly expanded the market.

This role is a full-time, fully benefited position. As a Kelly employee, you will be eligible for our enhanced benefits, 50% paid Medical & Dental, 401K, and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time. All Kelly employees in this group receive annual performance reviews.

In this role, you will provide technical leadership on a daily basis by developing, establishing, and maintaining quality engineering methodologies, systems, and practices. This position will also drive product/process improvements with the objective of product safety and high customer satisfaction.

Description of Work

  • Must be able to interface well with Management, Manufacturing and R&D Engineering, and Supply Chain.
  • Work with various departments to ensure timely closure of CAPAs, NCMRs, and Complaints. Document deficiencies, including root cause, corrective and preventive action plans. Ensure action plans are implemented in a timely manner.
  • Lead and support test method validation plans/protocols and reports.
  • Assist with risk analysis activities and maintaining up-to-date risk management documents.
  • Establish Quality Inspection Plans for the release of components, assemblies, and finished devices. Conduct quality inspections as needed.
  • Support Manufacturing with equipment qualifications (IQ/OQ/PQ), process validations and process improvements. Includes the use of various statistical techniques and quality tools.
  • Experienced with statistical techniques, including design of experiments (DOE); able to analyze results.
  • Evaluate significant product and/or process changes and enhancements that reduce defects, improve yields, and lower product cost.
  • Support quality management programs such as supplier selection and certification. Perform supplier evaluations as needed to assure supplier capabilities including the assessment of the adequacy of inspection methods, manufacturing practices, and control and quality procedures to deliver conforming products in a timely manner.
  • Lead supplier audits and works with suppliers to resolve audit findings and/or nonconformances.
  • Perform internal audits as needed.
  • Responsible for quality engineering review of Document Change Orders.
  • Devise and review specifications for products or processes.
  • Set requirements for raw materials or intermediate products for suppliers and monitor their compliance.
  • Ensure adherence to regulatory requirements, and health and safety guidelines.
  • Supervise inspectors, technicians and other staff and provide guidance and feedback.
  • Oversee all product development procedures to identify deviations from quality standards.
  • Inspect final output and compare properties to requirements.
  • Manage the sterilization program.

Required Skills & Experience

  • Minimum of a BS in Mechanical Engineering, Biomedical Engineering, Process Engineering, or equivalent degree.
  • 4+ years of relevant experience in medical devices.
  • Highly motivated and self-directed with a strong sense of urgency, with an ability to pull in resources from other departments as required.
  • Ability to deliver, meet deadlines and be results-oriented.
  • Detail-oriented, thorough, and observant.
  • Excellent communication skills (oral, written, presentation) at different organizational levels.
  • Experience with root cause analysis tools and methods.
  • Investigations, NCMR, CAPA and complaints.
  • Understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820, ISO 13485, and ISO 14971.

Important information:

Applicants must be legally permitted to work in the United States immediately and without employer sponsorship.

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