Sr. Engineer - QA

Arthrex Manufacturing - Corkscrew, FL

Full-time - Mid Level

Corkscrew, FL

Miscellaneous Manufacturing

About the position

The Sr. Engineer - QA at Arthrex is responsible for overseeing various Quality Assurance functions in the manufacturing development of medical devices. This role involves participating in the design and development of medical devices, ensuring compliance with design specifications, and leading quality initiatives. The ideal candidate will have a strong background in engineering, particularly in quality control or assurance within a regulated industry, and will possess leadership skills to mentor team members.

Responsibilities

• Participates in the development of medical devices and components from design initiation through design transfer, representing Quality Assurance for manufacturability.
• Leads the development of quality plans for new product introductions based on design specifications, PFMEA, and control plans.
• Works with the design team to provide feedback on design specifications and improvements.
• Evaluates and develops effective methods of testing and inspection of products.
• Utilizes problem-solving tools and techniques, applying a risk-based approach to problem-solving.
• Determines the necessity of testing and initiates testing by preparing test and inspection plans.
• Acts as the project leader for key initiatives and identifies best practices.
• Provides technical support on manufacturing technical issues.
• Performs quality trending and leads/supports process improvement initiatives.
• Approves manufacturing product and process changes, ensuring controlled and documented change management.
• Responsible for MRB activities for assigned products, resolving nonconformities, and monitoring corrective actions.
• Provides input and direction to other members of the quality assurance department to assist them in their assignments.
• Supports manufacturing suppliers with on-site resolution of quality and process-related issues.

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.
• 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, project implementation, including GD&T, DOE, verification, and validation.
• SPC (Statistical Process Control) knowledge.
• Strong communication skills to effectively communicate with technical and non-technical staff.

Nice-to-haves

• Project management skills preferred.
• Recognized process improvement training (i.e.: Lean, Six Sigma) and problem-solving training (i.e.: RCA, DMAIC, 5 Whys) 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 Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)