Engineer II - QA ACT

$92,000 - $143,750/Yr

Arthrex - Santa Barbara, CA

Full-time - Mid Level

Santa Barbara, CA

Miscellaneous Manufacturing

About the position

The Engineer II - QA at Arthrex is responsible for various Quality Assurance functions and design development activities of Class I and II medical devices, ensuring compliance with FDA, ISO, and CMDR Quality Systems and Design Control requirements. This role involves participating in design projects, conducting risk assessments, and collaborating with multifunctional teams to ensure product quality and safety.

Responsibilities

• Participates in the design of medical devices and components from design initiation through design transfer by representing Quality Assurance in all design and development project teams.
• Reports progress and status of assigned projects on a timely basis with emphasis on reporting results to Quality Assurance Management.
• Participates with multifunctional new product project teams in developing risk assessments, design inputs, test and inspection procedures, acceptance criteria, and complaint analysis.
• Utilizes problem-solving tools and techniques and applies a risk-based approach to problem-solving.
• Determines the necessity of testing and initiates testing of assigned products by preparing test and inspection plans, and identifying and obtaining required test fixtures and test/inspection instrumentation.
• Approves manufacturing and repair product and process changes and assures the change management is controlled, adequate, and documented.
• Ensures information and documentation is consistently accurate.
• Responsible for NCR activities for assigned products, timely resolution of nonconformities, issuing and/or monitoring corrective actions associated with nonconformance and deviations.
• Provide input and direction to other members of the quality assurance department to assist them in their assignments and provide them with a learning experience.
• Work with Manufacturing Engineers and Service Engineers in troubleshooting failures, repairs, and evaluating devices in the Repair and Production Department.

Requirements

• Bachelor's degree in Engineering required.
• 2 years' experience in Quality Control or Quality Assurance related activities; preferably in a Medical Device Company.
• Working knowledge of risk assessments, design control requirements, PFMEAs, control plans, quality plans, testing and inspection equipment and techniques as they relate to their device responsibilities.
• Manufacturing process knowledge.
• Technical knowledge in development methodologies, design, and project implementation, including GD&T, DOE, verification, and validation.
• Thorough knowledge of FDA, ISO13485 and CMDR Quality System Requirements, ISO 14971 Risk Management Standard to medical devices, EN60601, medical equipment safety and EMC, and RoHs Directives.

Nice-to-haves

• Experience with medical device capital equipment and software validation preferred.
• SPC (Statistical Process Control) knowledge is preferred.
• Project management skills preferred.
• Recognized process improvement (i.e.: Lean, Six Sigma) and problem-solving (i.e.: RCA, DMAIC, 5 Whys) training preferred.

Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Lunch
• Gym Reimbursement Program
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Paid Sick Leave
• Volunteer PTO
• Employee Assistance Provider (EAP)