Engineer I, Quality Systems (Computer System Validation)
Description For Engineer I, Quality Systems (Computer System Validation)
Axogen, a leading medical device company, is seeking an Engineer I, Quality Systems (Computer System Validation) to join their innovative team. This role presents an exciting opportunity to contribute to the company's mission of restoring health and improving quality of life through peripheral nerve function restoration.
The position offers a comprehensive benefits package effective from day one, including health, dental, and vision insurance, 401(k) matching, and various flexible spending accounts. The company promotes a friendly, open culture that values unique perspectives and maintains a strong commitment to professional growth.
As an Engineer I, Quality Systems, you'll be responsible for supporting IT and business system owners in computer system validations and data integrity assessments. This role is perfect for someone with a Bachelor's degree in Biomedical, Mechanical Engineering, or related field, who is starting their career in the medical device industry.
Key responsibilities include reviewing validation deliverables, collaborating on risk assessments, contributing to validation planning, and supporting audit processes. The role requires excellent communication skills, strong organizational abilities, and the capability to manage multiple priorities effectively.
The position offers a competitive salary range of $61,194 - $76,491 USD and follows a hybrid work schedule with 3 days in office and 2 days remote. This is an excellent opportunity for someone looking to build a career in quality systems engineering while making a meaningful impact on patient care.
The company's commitment to innovation, patient care, and professional development makes this an ideal role for candidates seeking to grow their careers in the medical device industry. You'll be part of a team that directly contributes to improving patient outcomes while working in a supportive, growth-oriented environment.
Responsibilities For Engineer I, Quality Systems (Computer System Validation)
- Review validation deliverables for compliance with procedures and regulatory requirements
- Collaborate on validation and data integrity risk assessments
- Support drafting and review of changes, deviations, and quality records
- Participate in risk assessments for investigations and process improvements
- Contribute to validation planning for new systems and processes
- Write and revise procedures for CSV/DI
- Develop and deliver training on CSV/DI
- Support internal and external audits
- Up to 25% travel required
Requirements For Engineer I, Quality Systems (Computer System Validation)
- Bachelor of Science Degree in Biomedical, Mechanical Engineering, Engineering Technology or similar
- 0-2 years of experience in pharmaceutical or medical device industry
- Experience with computerized systems in regulated industries and 21 CFR Part 11 compliance (preferred)
- Excellent oral and written skills
- Excellent interpersonal and team building skills
- Well-organized with ability to manage multiple priorities
Benefits For Engineer I, Quality Systems (Computer System Validation)
- Health Insurance
- Dental Insurance
- Vision Insurance
- 401(k) Matching
- 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
- Disability Insurance
- Annual Bonus Eligible
- Flexible Working Hours
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