Manager, Quality Systems in Mechanicsville, VA at Owens & Minor, Inc.

Date Posted: 10/2/2018

Job Snapshot

Job Description

POSITION SUMMARY

 

Manages the development, deployment, and continuous improvement of an efficient and effective Global Quality System across all Owens & Minor business units.  Ensures Owens & Minor's Global Quality System is compliant with applicable standards and regulations.  Manages the corporate quality audit program.  Manages and leads projects under the global quality project portfolio.

ESSENTIAL JOB FUNCTIONS: 

1.       Participates in the planning and design of the Owens & Minor Global Quality System that document harmonized processes for achieving quality policies and objectives, meet customer and regulatory requirements, are continuously monitored and improved, and are devoid of complexity that reduces effectiveness and/or efficiency, and empowers teammates to improve outcomes.

2.       Leads the deployment of the Global Quality System in an effective and efficient manner.

3.       Prepares the Global Quality System Management review from the compilation of the pertinent data through to the follow up of any resulting actions.

4.       Manages the program to conduct Owens & Minor's quality systems compliance audits.  Identifies and facilitates a team of qualified independent auditors, and maintains a centralized log of all internal and third party audits, findings, and status of responses.  Leads the centralized maintenance of all documentation and 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.

5.       Proactively performs data analysis to monitor Quality Systems performance and compliance, and identify opportunities to improve the Owens & Minor Global Quality System as applicable.

6.       Manages the global project management portfolio and actively leads projects as required

SUPPLEMENTAL JOB FUNCTIONS:  

1.       Complies with all standard operating procedures relevant the work.

2.       Complies with the requirements of the Quality System and relevant standards.

3.       Performs additional duties as directed.



Qualifications

EDUCATION & EXPERIENCE REQUIRED:  

  • Four year university degree required; Masters Degree preferred
  • Minimum of seven (7) years of related experience in a medical device or other relevant industry
  • In depth knowledge of quality systems standards and regulations ( ISO 9001, ISO 13485 and FDA QSR)

KNOWLEDGE SKILLS & ABILITIES:

  • Communicates effectively and persuasively, both verbally and in writing
  • Ability to work on own initiative, be proactive, and propose viable solutions to meet the business and customers' needs
  • Desire to lead change whilst meeting both the Business and Regulatory requirements.
  • Fluency in English
  • Must have a flexible approach to work and be capable of handling multiple priorities in a fast-paced environment
  • Strong attention to detail with a high degree of accuracy and excellent organizational and communication skills.
  • Ability to work with and empathize with colleagues and customers from varied backgrounds and cultures
  • Must actively demonstrate Owens & Minor's core values:
    • We seek simplicity: With every interaction, we demonstrate that it is easy to do business with the company.
    • Credibility is our currency: We must operate with integrity so that our words, our work, and our people can be relied upon as trustworthy and steady.
    • We are connected by purpose: We believe that the power of collaboration helps make healing happen for the patients our customers serve.
    • Outcomes are our difference: is our job to ensure the right solutions are available in the right place at the right time


ADDITIONAL REQUIREMENTS:  

Ability to travel up to 20%

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