Job Description:
Axogen is committed to building and maintaining a strong and gratifying company culture that fosters a work-life balance and 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 the leading company revolutionizing the science of nerve repair. We are passionate about helping to restore function and quality of life to patients with physical damage or discontinuity to peripheral nerves.
Contribute to positively impacting lives while working for a company that respects, recognizes, and values all team members!
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 is hiring 2 Quality Assurance Supervisors in Vandalia, OH!
Job Summary of the Supervisor, Quality Assurance
The Quality Assurance (QA) Supervisor oversees and supports the quality team in quality oversight to Axogen's manufacturing, processing, systems, testing and product distribution functions. The role will utilize industry and quality assurance experience in Human Tissue, Medical Device and Biologics with emphasis on Quality and Regulatory Compliance. This role will report to the Quality Assurance Manager at Burleson Distribution Center (BDC).
Requirements of the Supervisor, Quality Assurance
- Bachelor's Degree in Life Science discipline and/or a related field.
- Minimum of 5 years in a Quality Engineering/Quality Assurance role for medical device or pharmaceutical manufacturing preferred.
- Minimum of (1) years supervisory experience preferred.
- Quality system regulations and requirements (specifically; 21 CFR part 820, 21 CFR Part 1270/1271, 21 CFR Part 210/211, ISO 13485, ISO 14971).
- Experience in leading external regulatory and/or third-party audits, i.e. FDA, ISO, etc.
- Experience with Review and Approval of IQ/OQ/PQ Protocols and Reports.
- Experience with Process Validation/PPQ methodologies.
- Lean/Six Sigma certification preferred.
- Lead Auditor Certification preferred.
- Travel Requirements are up to 10%
- Knowledge of current Good Manufacturing Practices (cGMP) and relevant regulatory standards, guidelines, and regulations, both in the US and OUS for tissue, Medical Devices and/or Biologics.
- Knowledge of statistical sampling and analysis.
- Knowledge of Root Cause Analysis (RCA) methodologies.
- Skill in oral and written communication.
- Skill in organizational techniques and practices.
- Skill in interpersonal and team building techniques.
- Ability to proficiently use MS Office Suite, including Microsoft Visio and Project.
- Ability to exercise creativity and demonstrate good judgment
- Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information and problem solve.
Responsibilities of the Supervisor, Quality Assurance
The specific duties of the Supervisor, Quality Assurance include but are not limited to:
- Manages team of Quality Inspectors and support personnel including performance reviews and development plans.
- Serves as subject matter expert when issues or questions arise for Tissue, Medical Device or Biologic regulations (international and domestic).
- Confers with external and internal departments (example Product Development, Clinical, Marketing, Sales, and Operations) concerning product design to ensure user needs are met.
- Engages in and provides quality oversight of the selection, development, and qualification/validation of tools, fixtures, machinery, and equipment used in manufacturing
- Leads and participates in quality risk management activities to ensure regulatory compliance for products, methods and materials.
- Provides quality oversight in the identification and documentation of product and material specifications.
- Leads Quality Planning activities in Facility development including verification and validation plans and reliability strategies
- Leads Quality Planning activities for new and existing processes, including verification and validation plans and reliability strategies.
- Investigates manufacturing processes for non-conformance reduction and inspection optimization
- Confers with purchasing and logistics to maintain the supplier management program and to track supplier quality metrics.
- Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
- Ensures compliance with CGMP, QSR, ISO13485, MDD, and other applicable regulations/standards
- Prepares reports, metrics, and presentations by collecting, analyzing, and summarizing data; making recommendations and sharing results with appropriate stakeholders
- 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.
- Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
- Recruits, develops, and manages the Quality Assurance department as the company's pipeline and development activities grow.
- Supports inspections and audits from external bodies, as well as collaborating on responses to audit and inspection observations.
- Performs all other duties as assigned.
- Responsible for leading Quality Inspectors.
- Establishes, implements, and maintains Axogen's Quality Management System at BDC
- Performs and oversees Qualification/Validation activities for support of BDC location.
- Trains BDC organization on Quality and compliance policies
- Supports communication of major changes to facility, process, materials, and systems to the regulatory team
- Supports on-site audits and inspections conducted at the BDC location
- Performs budget development for projects and ensures project timelines are met.
- Design and implement inspection methods (including AQL), equipment, acceptance criteria and sampling plans.
- Performs First Article Inspections to ensure Manufacturing process capability.
- Participates in FDA inspections, ISO Certification, surveillance audits and customer audits.
- Deploys proactive quality controls for consistent and predictable quality outcomes
- Leads or assists with Nonconformance/Deviation and CAPA activities
- Participates in Quality System monitoring and measurement activities.
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 + 2 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
$86,994-$108,743 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.
If you know someone who would be a great candidate for this position, or any others, just copy and send this link! https://grnh.se/cc84962d2us
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