Maintain programs in support of the quality system, specifically related to internal auditing and customer audits for FDA regulations, AATB and ISO Standards. This includes participating in audits and maintaining audit documentation.
Pay: $68,828 - $93,765/yr based on relevant years of experience
Bonus: 10% target Bonus Program based on individual and company metrics
Shift: Monday-Friday; 8:00am – 5:00pm
Benefits: Generous Time Off Policy, Paid Sick Leave, 9 paid Holidays, Retirement Plan, onsite Health Care clinic, Wellness Program, Life Insurance, AD&D, Short & Long Term Disability, and more!
Location: 6278 S. Troy Circle, Centennial, CO 80111
Essential Duties and Responsibilities:
- Perform audits to ensure adherence to the annual internal audit schedule.
- Execute internal audits as assigned.
- Provides thorough, succinct, evidence based audit reports and notes compiled during audits.
- Participate in customer audits as needed and respond internally to audit findings.
- Provide assistance to Regulatory and Quality Management for applicable procedure writing, maintenance of accreditations and certifications.
- Complete customer quality/regulatory surveys, maintain survey files.
- Provide reports for applicable quality metrics.
- Assist with regulatory body audits as required.
- Assist with Supplier Quality audits as required.
- Adhere to and promote proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices and company policies.
- Bachelor’s degree
- In lieu of degree, 9 years’ working in a regulated industry with direct auditing experience
- Auditor certification (ex. Certified Quality Auditor, Certified Biomedical Auditor, Certified Lead Auditor)
- 5-7 years’ regulatory/quality experience in an FDA regulated industry (ex. tissue banking, medical device, biologics, or pharmaceutical)
- 3 years’ direct auditing experience in an FDA regulated environment
- Previous experience in a position that requires multi-department interactions
- Proficiency in Microsoft Office applications
- Bachelor’s degree in a scientific or technical field.
- Knowledge of and experience in auditing Medical Device Quality Systems [ISO 13485, 21 CFR 820]
For consideration you must apply online, submit a current resume and meet the minimum requirements. All offers are contingent upon a background check, drug screen and other contingencies may apply depending upon the position. Candidates within a 50 mile radius of the hiring zip code may receive first consideration. If you require special accommodations, please contact us at 720-873-0213.
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