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
If you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories:
Axogen is hiring a Quality Engineer in Dayton, OH!
Job Summary of the Quality Engineer
This position is responsible for providing Quality Engineering support for process validation, process improvements, compliance projects and manufacturing support. In your role, you will identify and assess regulatory and quality risks in manufacturing activities and processes per regulatory requirements for Axogen's products. This role will work closely with the Quality Engineering and Site Operations and Engineering teams to plan, organize and perform commissioning, qualification and validation for defined processes, facilities, equipment and process controls that meet applicable regulatory and company requirements. The role shall be familiar with the qualification of biologics/pharmaceutical facilities, manufacturing equipment/systems, sterilization processes, cleaning processes, environmental monitoring, and process validation runs.
Requirements of the Quality Engineer
- Bachelor's degree in Biomedical Engineering, Pharmaceutical Sciences, and/or in a related degree.
- Minimum of 3 years' experience in Quality Engineering in a regulated manufacturing site.
- Experience working in pharmaceutical or biologic cGMP areas such as 21 CFR Part 210/211, 21 CFR Part 600.
- Knowledge of statistical analysis tools and familiarity with equipment qualification and process validation.
- Experience with Advanced Therapy Medicinal Products (ATMP), Tissue, or biologics is a plus.
- Experience with Medical Device (21 CFR 820/ISO 13485) manufacture or regulated tissue processing (21 CFR 1271) is a plus.
- ASQ CQE certification is a plus.
- Proficient in Electronic Quality Management Systems.
- Must be able to handle multiple projects concurrently.
- Strong Analytical Skills, Critical Thinking and Problem-Solving Skills, Attention to Detail.
- Strong Communication and Team working skills, with ability to influence decisions.
- Travel Requirements are up to 10%.
Responsibilities of the Quality Engineer
The specific duties of the Quality Engineer, but are not limited to:
- Provide quality engineering support for equipment qualification and process validations as required.
- Assist, in a team-based approach, the development and improvement of manufacturing processes to ensure such processes meet Axogen's standards of process capability, reliability, and repeatability.
- Coordinate supplier and material qualification with manufacturing engineering teams and Supplier Quality team.
- Collaborate on the design and implementation of in-process control and incoming inspection test methods, acceptance criteria and sampling plans & rationale.
- Ensure effective quality by design support for process improvement activities and technology transfer to production floor.
- Act as a Quality representative supporting issue identification and resolution by applying root cause methodologies.
- Determine quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
- Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
- Provide department support during FDA, Notified body, and other external or internal audits.
- Provide department support during any product recall or market withdrawal.
- Create, maintain, and support Quality System processes and procedures related to quality engineering activities.
- Comply with all company policies, procedures, and SOPs.
- Perform all other duties assigned by quality management
If you know someone who would be a great candidate for this position, just copy and send this link!
Location
Dayton Processing Center (DPC)
349 South Mainstreet 4th Floor
Dayton, OH
#LI-AC1
.
|
Worldwide Equipment |
|
Worldwide Equipment |
|
Worldwide Equipment |
|
Eurofins Lancaster Laboratories Professional Scientific Services, LLC |
|
TestAmerica Laboratories |
|
TestAmerica Laboratories |