Engineer I, Quality Systems (Computer System Validation)
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 IT and business system owners on the design, execution, and review of computer system validations (CSV) and data integrity (DI) assessments. This role is further responsible for the creation, revision, and review of controlled documents relating to CSV and data integrity. This role will provide quality engineering and quality assurance support for all Axogen sites and departments, ensuring 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 one year of experience in the pharmaceutical or medical device industry required - Working experience with computerized systems in regulated industries and 21 CFR Part 11 compliance is preferred
- Ability to exercise creativity and judgement
- 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:
- Review of draft and executed validation deliverables to ensure compliance with Axogen procedures and applicable regulatory requirements
- Collaborate with system and process owners on completing validation and data integrity risk assessments
- Support the drafting and review of changes, deviations, periodic reviews, and associated quality records concerning computerized system and/or data integrity issues
- Participate in risk assessments supporting investigations and process improvements
- Contribute to validation planning for new systems and processes
- Write and revise procedures and controlled documents governing CSV/DI by collaborating with IT, QA, and applicable departments
- Develops and/or delivers training on CSV/DI to applicable personnel
- Supporting internal and external audits and inspections
- Other duties as assigned by manager
- This role will involve up to 25% travel
Location
13631 Progress Blvd., Alachua, FL 32615
OR
111 West Oak Ave., Tampa, FL 33602
OR
913 Industrial Drive Place, Vandalia, OH 45377
#LI-AC1
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.
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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By
Axogen
Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve, or the inability to properly reconnect peripheral nerves, can result in the loss...
28 jobs
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