Engineer II QA

Arthrex Manufacturing - Corkscrew, FL

Full-time - Mid Level

Corkscrew, FL

Miscellaneous Manufacturing

About the position

The Engineer II - QA position at Arthrex involves ensuring the quality and compliance of medical devices through various quality assurance and control processes. The role requires collaboration with suppliers, training of quality control inspectors, participation in audits, and leading risk management initiatives. The ideal candidate will contribute to continuous improvement projects and support the engineering change management process, all while working in a dynamic manufacturing environment.

Responsibilities

• Review design drawings for tolerance, inspect-ability and quality of design issues.
• Work with suppliers to improve quality and assist in supplier process validations.
• Assist in the training of QC Inspectors on inspection techniques and the use of new equipment.
• Participate in Internal and External quality audits as directed by the Quality Assurance Manager.
• Support Risk Management by leading or participating in cross-functional team pFMEA's and Risk Assessments.
• Support the AMI Engineering Change Management process by performing tasks as assigned.
• Lead or Support the internal manufacturing First Article Inspection process, review First Article Inspection Reports and samples.
• Lead or Support equipment or process validation (IQ, OQ, PQ).
• Lead or support Metrology with design and development of inspection methods and gages.
• Create or review inspection method work instructions.
• Lead or support Metrology with Measurement System Analysis (Gage R&R) studies.
• Create Inspection Plans Supporting Receiving and In-Process Inspection.
• Investigate complaints as requested by the Complaints/Reliability team.
• Lead completion of Nonconformances (NCR's) as assigned: material disposition plans, evaluations, and action plans.
• Perform routine Nonconformance and process trending and lead periodic Quality review meetings with the management team.
• Lead or Support Continuous Improvement projects.
• Lead or support the Environmental Monitoring program.
• Complete Root Cause Analysis Investigations and define Corrective/Preventive Action Plans (CAPA's).
• Perform Engineering Studies and Design of Experiments (DOE) as needed.

Requirements

• Bachelor's degree in Engineering required.
• 2 years experience in a Quality Control or Quality Assurance position in a Medical Device Company preferred.
• Technical knowledge in development methodologies including Design Controls, GD&T, DOE, Process Verification and Validation.
• SPC (Statistical Process Control) knowledge.
• Working knowledge of process improvement tools (i.e.: Lean - PDCA, Six Sigma - DMAIC) and problem solving (i.e.: Kepner Tregoe, Lean A3, 5 Whys) preferred.
• Working knowledge of risk assessments, PFMEAs, control plans, quality plans.
• Strong communication skills and ability to communicate effectively with technical and non-technical staff.
• Project management skills preferred.
• Proficiency in the use of PC and programs, particularly Excel, Word, miniTab or similar statistical analysis software, SAP or similar inventory software, Agile or similar design lifecycle software, Pilgrim or similar QMS software.
• Knowledge of measurement and other inspection equipment.

Nice-to-haves

• Working knowledge of risk assessments, PFMEAs, control plans, quality plans.
• Project management skills 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)