Engineer Sr. I - QA ACT

$109,250 - $156,688/Yr

Arthrex - Santa Barbara, CA

Full-time - Mid Level

Santa Barbara, CA

Miscellaneous Manufacturing

About the position

The Engineer Sr. I - QA at Arthrex is responsible for overseeing various Quality Assurance functions and design development activities for Class I and II medical devices, ensuring compliance with FDA, ISO, and CMDR Quality Systems and Design Control requirements. This role involves participating in the development of medical devices, reporting project progress, and leading quality assurance initiatives to improve processes and resolve nonconformities.

Responsibilities

• Participates in the development of medical devices and components from design initiation through design transfer, representing Quality Assurance for manufacturability.
• Reports progress and status of assigned projects to Quality Assurance Management.
• Participates in manufacturing and repair activities to ensure compliance with design specifications.
• Utilizes problem-solving tools and techniques, applying a risk-based approach to problem-solving.
• Determines the necessity of testing, prepares test and inspection plans, and identifies required test fixtures and instrumentation.
• Initiates new projects and acts as the project leader for key initiatives, identifying best practices.
• Performs quality trending and leads/supports process improvement initiatives.
• Approves manufacturing and repair product and process changes, ensuring controlled and documented change management.
• Ensures accuracy of information and documentation.
• Responsible for NCR activities for assigned products, resolving nonconformities, and monitoring corrective actions.
• Provides input and direction to other quality assurance department members, assisting in their assignments.
• May supervise other engineers, quality specialists, and support personnel.
• Analyzes repair data using statistical analysis tools to identify adverse trends and recommends actions to reverse them.
• Works with Manufacturing Engineers and Service Engineers to troubleshoot failures and evaluate devices.

Requirements

• Bachelor's degree in Engineering required.
• 5 years' experience in a Quality Control or Quality Assurance position required, preferably in a medical device company.
• Experience with medical device capital equipment and software validation preferred.
• Working knowledge of risk assessments, design control requirements, PFMEAs, control plans, quality plans, testing and inspection equipment and techniques.
• Manufacturing process knowledge.
• Technical knowledge in development methodologies, design, and project implementation, including GD&T, DOE, verification, and validation.
• SPC (Statistical Process Control) knowledge.
• Thorough knowledge of applicable medical device regulations for electrical safety and EMI/EMC.
• Quality/Design Assurance Experience with Medical Capital Equipment.
• Strong communication skills to effectively communicate with technical and non-technical staff.
• Project management skills preferred.

Nice-to-haves

• Recognized process improvement training (i.e.: Lean, Six Sigma) and problem-solving training (i.e.: RCA, DMAIC, 5 Whys).

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)