Engineer I, Quality Systems (Computer System Validation)
Axogen, Inc.

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

If you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories: https://www.axogeninc.com/patient-stories/

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 I, Quality Systems (Computer System Validation)

The Engineer I, Quality systems will provide support to Operations and Quality with document control, record control, and QMS administration at the Axogen Processing Center. This role is further responsible for the creation, validation, and maintaining compliance of procedures with document and record control. This role will provide quality engineering and quality assurance support for manufacturing operations to ensure new and current medical products and processes are in compliance with applicable standards and regulations.

Requirements of the Engineer I, Quality Systems (Computer System Validation)

• Minimum of Bachelor of Science Degree in Biomedical, Mechanical Engineering, Engineering Technology or similar required
• Minimum of one year of experience in the pharmaceutical or medical device industry required
• Working experience with document and record control in regulated industries is preferred
• Ability to exercise creativity and judgment
• Excellent oral and written skills
• Excellent intrapersonal and team-building skills
• Well-organized, with the ability to efficiently manage multiple, competing priorities

Responsibilities of the Engineer I, Quality Systems (Computer System Validation)

The specific duties of the Engineer I, Quality Systems include but are not limited to:

• Generation, issuance, and reconciliation of executable documents, including maintaining and improving the system in consultation with site Operations and Quality
• Filing, organization, and maintenance of document control room, including shipment of files off-site for archival
• Performing document and training administrator role in the electronic quality management system (eQMS) for APC-specific documents
• Participate in risk assessments supporting investigations and process improvements
• Contribute to validation planning for new systems and processes
• Acting as a liaison between authors and approvers as needed to ensure timely and accurate processing of documents and workflows
• Write and revise procedures and controlled documents governing quality processes for APC by collaborating with senior engineers and leadership
• Support site operations in the execution, trending, and reporting of the quality management system (deviation, CAPA, change control, etc.)
• Supporting the creation and assignment of training materials and roles in the eQMS
• Supporting internal and external audits and inspections by providing reports from the eQMS and retrieving files

Location

13631 Progress Blvd., Alachua, FL 32615

OR

111 West Oak Ave., Tampa, FL 33602

OR

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

$61,194-$76,491 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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