Sr. Engineer, Quality

About the role

Axogen’s mission is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. The Sr. Quality Engineer will provide Quality and Compliance support for development, manufacture and distribution of healthcare products in accordance with applicable Quality Management regulations (International and Domestic regulations for Biologic, Human Tissue, Medical Device products). The role exercises independent judgment in engineering methods, techniques and evaluation criteria, creates formal networks across groups, and has broad expertise or unique knowledge in Engineering. May supervise a small team of direct reports and uses skills to contribute to company objectives.

Responsibilities

• Confer with external and internal departments (Product Development, Clinical, Marketing, Sales, Operations) to ensure user needs are met.
• Evaluate product design for manufacturability and suggest design process adjustments and quality improvements.
• Select, develop, and qualify/validate tools, fixtures, machinery, and equipment used in manufacturing.
• Lead and participate in risk management activities.
• Lead quality issue resolution by applying root cause methodologies.
• Ensure effective design control and transfer to production.
• Lead Quality Planning activities for new product development projects, including verification and validation plans and reliability strategies.
• Lead Quality Planning activities for facility development, new and existing processes, including verification and validation plans and reliability strategies.
• Investigate manufacturing processes for non-conformance reduction and inspection optimization.
• Determine quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
• Prepare reports and presentations by collecting, analyzing, and summarizing data; make recommendations.
• Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, benchmarking state-of-the-art practices, and participating in professional societies.
• Collaborate with supply chain partners to assure product quality.
• Confer with purchasing and logistics to maintain the supplier management program.
• Design and implement inspection methods, equipment, acceptance criteria and sampling plans.
• Initiate or assist in cost reductions of product inspections.
• Provide validation, sampling, and statistical analysis support to other functions in the organization.
• Perform First Article Inspections to ensure manufacturing process capability.
• Ensure compliance with CGMP, QSR, ISO 13485, MDD, and other applicable regulations/standards.
• Participate in FDA inspections, ISO certification, surveillance audits and customer audits.
• Deploy proactive quality controls for consistent and predictable quality outcomes.
• Establish and implement metrics for monitoring system effectiveness.
• Report to management on quality issues, trends and losses.
• Provide functional support as needed for all team members and direct staff as needed.

Requirements

• Minimum of Bachelor of Science Degree in Biomedical, Mechanical Engineering, or Engineering Technology.
• Lean/Progressive Manufacturing and Quality disciplines.
• Fundamental understanding of design controls, project management, and basic manufacturing practices/processes.
• Minimum of 5 years in a Quality Engineering/Quality Assurance role for medical device or pharmaceutical manufacturing.
• Strong project management skills required.
• Demonstrated knowledge of statistical sampling and analysis.
• Demonstrated excellent organizational, writing and verbal communication skills.
• Proficient with the MS Office Suite, including Microsoft Visio and Project.
• Limit gauge design for dimensional verification.
• Problem solving using root cause methodologies (e.g., DMAIC).
• Applying statistics and software in data analysis (e.g., Minitab).
• Application of failure modes and effects analysis (FMEA).
• Working with suppliers to design inspection systems and resolve quality issues.
• Knowledge of quality system regulations and requirements (e.g., 21 CFR Part 820, 21 CFR Part 1271, 21 CFR Part 210/211, ISO 13485, ISO 9001, ISO 14971).
• Geometric Dimensioning and Tolerancing (GD&T) experience.

Preferred qualifications

• ASQ Certified Quality Engineer.
• Lead auditor certification.
• Six Sigma Black Belt.

Travel

Up to 30%.

Benefits

• Health, Dental, Vision insurance.
• Matching 401(k).
• Paid Time Off and 9 Paid Holidays plus 3 Floating Holidays.
• Dependent Care and Medical Flexible Spending Accounts.
• Tuition Reimbursement and Paid Parental/Caregiver Leave.
• Basic and Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance.

Pay

$84,190—$105,237 USD annually, with eligibility for an annual bonus.