Manager, Quality Systems Compliance at Axogen Inc in Alachua, Florida

Posted in Other 8 days ago.

Job Description:

Axogeniscommittedto building and maintaining a strong andgratifyingcompany 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!

Axogenis the leadingcompany revolutionizing thescience of nerve repair.We arepassionate about helping to restore function and quality of life to patients with physical damage or discontinuity to peripheral nerves.

Contributetopositively impactinglives whileworkingfor a company that respects, recognizes, andvalues allteam members!

Axogenis an equal opportunity employer and does not discriminate against applicantson the basis ofrace, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.

Why you'll love working atAxogen:

  • Friendly, open,andfunteam culturethat values uniqueperspectives

  • Company-wide dedicationto profoundly impacting patients' lives

  • Comprehensive, high-quality benefitspackage effective on date of hire

  • Educationalassistanceavailable for all employees

  • Matching 401(k)retirementplan

  • 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 atAxogen, take a look at theseinspiringpatient stories:

Axogen is hiring for an Manager,Quality Systems Compliance in Alachua or Tampa, FL!

Job Summary of the Manager,Quality Systems Compliance

The Manager, Quality Systems Compliance will provide leadership in the implementation, maintenance, and improvement of company-wide quality management systems,proceduresand support processes. Proactively monitors the various elements of the quality system to help ensure compliance with quality system regulations and applicable national and international quality standards.Ensuresprocessesand tools are established to ensure ongoing compliance with applicable requirements. Supports external audits by the FDA, AATB, the Notified Body, other regulatory bodies and third parties, and coordinates responses to applicable audit findings. Manages the internal audit program to ensure company-wide compliance to applicable standards, regulations, and internal procedures. Provides support to internal functions in the application, maintenance and improvement of quality systems and department specific processes. Promotes quality achievements and performance improvements throughout the organization.

Requirements of the Manager,Quality Systems Compliance

  • Bachelor's Degree in Engineering,Science, and/or in a related field.

  • Minimum of7 years' experience in an FDA regulated industry in medical devices and/or biologics.

  • Master's Degree or higherin Engineering is preferred.

  • Minimum of2 years of experience in a management role with demonstrated leadership skills.

  • Direct experience with FDA QSRs, ISO 13485, ISO 14971, MDD 93/42/EEC, 21CFR part 11, 210, 211, 600 and 1271 and AATB Standards.

  • Experience in leading external regulatory and/or third-party audits, i.e. FDA, ISO, AATB, etc.

  • Demonstrated experience in building high-performing quality and/or related organizational teams.

  • Excellent oral and written communication skills.

  • Excellent interpersonal and team building skills.

  • Ability to exercise creativity and judgment.

  • Travelrequirementsup to 25%.

Responsibilities of the Manager,Quality Systems Compliance

The specific duties of the Manager,Quality Systems Compliance include but are not limited to:

  • Ensuresthat Axogen's quality systemsare in compliance withthe applicable regulations and national & international quality standards

  • Provides support to internal functions in the application, maintenance and improvement of quality systems, procedures and department specific processes

  • Manages external audits by the FDA, AATB, the Notified Body, other regulatory bodies and third parties, and coordinates responses to applicable audit findings

  • Ensures the coordination between Axogen facilities so changes in the quality management system are implemented with consideration to compliance and changing business needs

  • Prepares performance reports and metrics for the Quality Management System

  • Provides hands-on ownership for quality systems improvement projects to ensure various elements of the quality system continue to support changing business needs and goals

  • Ensures efficient and effective processes and tools are established for compliance with AATB, QSR (21 CFR part 820), ISO 13485 standards requirements and 21CFR parts 11, 210, 211, and 1271

  • Performs all otherduties as assigned by Supervisor.

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13631 Progress Blvd., Alachua, FL 32615


111 West Oak Ave., Tampa, FL 33602