Sr. Engineer, Quality
Axogen
Summary
The Sr. Quality Engineer will provide Quality and Compliance related support for the 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 Sr. Engineer exercises independent judgment in engineering methods, techniques and evaluation criteria for obtaining results, creates formal networks involving coordination among groups, and has broad expertise or unique knowledge in Engineering.
Job description
Job Summary
The Sr. Quality Engineer will provide Quality and Compliance related support for the 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 Sr. Engineer exercises independent judgment in engineering methods, techniques and evaluation criteria for obtaining results, creates formal networks involving coordination among groups, and has broad expertise or unique knowledge in Engineering.
Responsibilities
- Confer with external and internal departments concerning product design to ensure user needs are met.
- Evaluate product design for manufacturability and suggest design process adjustments and quality improvements.
- Engage in the selection, development, and qualification/validation of 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 in Facility development including verification and validation plans and reliability strategies.
- Lead Quality Planning activities for 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; making recommendations.
- Collaborate with supply chain partners to assure quality of product.
- 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, ISO13485, 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.
- 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 (i.e. DMAIC)
- Applying statistics and software in data analysis (i.e. Minitab)
- Application of failure modes and effects analysis (FMEA)
- Working with suppliers to design inspection systems and resolve quality issues
- Quality system regulations and requirements (examples 21 CFR part 820, 21 CFR Part 1271, 21 CFR Part 210/211, ISO 13485, ISO 9001, ISO 14971)
- Geometric Dimensioning and Tolerance (GD&T) experience
- Travel up to 30%
Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- 401(k) Matching
- Paid Time Off
- 9 Paid Holidays
- 3 Floating Holidays
- Dependent Care FSA
- Medical FSA
- Tuition Reimbursement
- Paid Parental Leave
- Paid Caregiver Leave
- Basic Life Insurance
- Supplemental Life Insurance
- Employee Stock Purchase Plan
- Disability Insurance
- Annual Bonus
Company overview
Axogen, Inc. (NASDAQ: AXGN) is a leading medical device company exclusively focused on the science, development, and commercialization of innovative technologies for peripheral nerve regeneration and repair. As the only company solely dedicated to peripheral nerve repair, Axogen has pioneered a comprehensive portfolio of clinically proven solutions that address various types of nerve injuries. The company's flagship product, Avance Nerve Graft, is a biologically active processed human nerve allograft designed for bridging severed peripheral nerves without requiring a second surgical site. Axogen's product line also includes the Axoguard family of products - Nerve Connector, Nerve Protector, and Nerve Cap - which utilize porcine extracellular matrix technology to protect and repair damaged nerves. With operations in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and other countries, Axogen is committed to restoring nerve function and improving quality of life for patients suffering from peripheral nerve injuries through innovative, clinically validated, and economically effective surgical solutions.