AxoGen
Engineer II, Quality
AxoGen, Vandalia, OH, United States
Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!
Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.
Why you'll love working at Axogen:
- Friendly, open, and fun team culture that values unique perspectives
- Company-wide dedication to profoundly impacting patients' lives
- Comprehensive, high-quality benefits package effective on date of hire
- Educational assistance available for all employees
- Matching 401(k) retirement plan
- Flexible working hours
- Paid holidays, including floating holidays, to be used at your discretion
- Employee Stock Purchase Plan
- Referral incentive program
Axogen Mission and Business Purpose
Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.
Job Summary of the Engineer II, Quality
The Quality Engineer II provides quality engineering and quality assurance support for New Product Development Teams and Manufacturing Operations to ensure new/improved and current medical products and processes are in compliance with applicable standards and regulations.
Requirements of the Engineer II, Quality
- Bachelor's Degree in Engineering or related degree plus a minimum of 3 years' experience in manufacturing, product development or quality engineering with a medical device or biotech company
- Limit gauge design for dimensional verification.
- Problem solving using root cause methodologies (i.e. DMAIC);
- Applying statistics and software in data analysis (example 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)
- ASQ Certified Quality Engineer preferred
- Lead auditor certification preferred
- Six Sigma Black Belt preferred
The specific duties of the Engineer II, Quality include but are not limited to:
- Confer with external and internal departments (Product Development, Clinical, Marketing, Sales, and Operations) concerning product design to ensure user needs are met.
- Lead and participate in risk management activities.
- Lead Quality Planning activities for new product development projects, including verification and validation plans and reliability strategies.
- Contribute to validation planning for new and existing processes.
- Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
- Prepares reports and presentations by collecting, analyzing, and summarizing data; making recommendations.
- Maintains 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 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.
- Ensure effective design control and transfer to production.
- Provide validation, sampling, and statistical analysis support to other functions in the organization.
- Lead Quality issue resolution by applying root cause methodologies.
- Perform First Article Inspections to ensure Manufacturing process capability.
- Participate in FDA inspections, ISO Certification, surveillance audits, and customer audits
- Deploying 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
Location
913 Industrial Drive Place, Vandalia, OH 45377
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Benefits/Compensation
This position is eligible for an annual bonus. Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.
Salary Range
$67,313-$84,141 USD
Axogen is on a hybrid work schedule for some of our positions based out of our headquarters in Florida, with 3 days in office and 2 days remote. The hybrid work schedule does not include sales or facilities in Ohio or Texas.
Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.
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