Manager, Regulatory & Quality Compliance in Alpharetta, GA at Owens & Minor, Inc.

Date Posted: 9/18/2019

Job Snapshot

Job Description

The QARAC Audit Manager is a key contributor to the success of the Owens & Minor QARA organization.  The Audit Manager is responsible for establishing an efficient and effective global program to audit quality systems and compliance areas such as FCPA.  This is a global role that supports all Business Units and ensures the Owens & Minor Global QARAC Audit Program is compliant with applicable standards and regulations.  Tracks and trends audit observations from internal and third party audits and regulatory inspections to identify improvement opportunities.



ESSENTIAL JOB FUNCTIONS: 

1.1.    Establishes an Owens & Minor Global QARAC Audit program that:

              Harmonizes QARA and Compliance internal audit processes across Owens & Minor to meet customer and regulatory requirements;

              Is continuously monitored and improved;

              Is executed by proficient auditors using appropriate audit protocols;

              Is devoid of complexity that reduces effectiveness and/or efficiency and empowers teammates to improve outcomes.

1.2.    Supports the effective execution of the QARAC audit program:

              Responsible for identifying and facilitating a team of qualified, independent internal QARAC auditors.

              Maintain a centralized log of all internal and third party audits, findings and status of responses.

              Accountable for the centralized maintenance of all documentation including subsequent follow up, tracking and closure of any findings that result from such audits.

              Facilitates the sharing of best practices / learnings and initiatives from the quality system audit program throughout Owens & Minor.

              Identifies and shares industry best practices.

              Conducts proactive data analysis and promotes a culture of continuous improvement to identify opportunities and improve the Owens & Minor global quality and compliance systems. Ensures monthly reports are available on key process metrics and are represented on the global dashboard.

SUPPLEMENTAL JOB FUNCTIONS:  

1.      Performs additional duties as directed. 



Qualifications

EDUCATION & EXPERIENCE REQUIRED:  

         Holds a minimum 4 year university degree.

         Minimum 5 years experience in a Medical device industry or a similar environment. 

         Minimum of three years experience in quality system or compliance audits.  Auditor certification required, lead auditor certification preferred.

         Is trained / knowledgeable in Quality Systems standards and regulations, i.e. ISO 9001, ISO 13485 and FDA QSR.

KNOWLEDGE SKILLS & ABILITIES:

  • Fluency in English.
  • Ability to work on own initiative, be proactive and propose viable solutions to meet the business and customers needs.
  • Excellent communication skills, both oral and written.
  • Desire to lead change and meet both the Business and Regulatory requirements.


ADDITIONAL REQUIREMENTS:  

         Ability to travel up to 20%

        Note: Owens & Minor is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at our Company via email, the Internet, or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of our Company. No fee will be paid in the event the candidate is hired by our Company as a result of the referral or through other means.

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