Quality Systems Manager in Louisville, KY at Owens & Minor, Inc.

Date Posted: 8/2/2019

Job Snapshot

Job Description

POSITION SUMMARY

 

Quality professional accountable for Quality Management System activities while supporting continuous improvement initiatives. Internally, the candidate will own the quality management system, drive effective internal controls and processes while working with cross-functional teams and leadership to enact improvements. The manager will be the Quality Systems subject matter expert and interact with regulatory bodies and customers during audits and respond to information requests.



ESSENTIAL JOB FUNCTIONS: 

1.       Process owner for all relevant quality system elements including but not limited to Management Review, CAPA, change control, and document control.  Provide direction and leadership in these areas, driving accountability both within the quality organization and cross-functionally.

2.       Develop and maintain simplified Standard Operating Procedures (SOPs) and Work Instructions (WIs) for the quality system.

3.       Drive quality programs and initiatives to meet quality objectives for the business unit. Implement measurement systems and monitor relevant trends for key performance indicators (KPIs).  Provide analysis and interpretation of KPIs to support data driven decision making.

4.       Ensure that CAPAs are opened as needed and are resolved in a timely and effective manner; supports root cause analysis through training and hands-on assistance.

5.       Maintain the master validation plan, conduct validations or qualification tests of new or existing equipment, processes or software in accordance with internal protocols.

6.       Schedule and prepare management reviews to provide updates on the quality management system and recommendations for improvement.

7.       Maintain the internal audit schedule, support third party audits and regulatory inspections.  Establish tracking mechanism for all audit/inspection findings.

SUPPLEMENTAL JOB FUNCTIONS:  

1.       Performs additional duties as directed.



Qualifications

EDUCATION & EXPERIENCE REQUIRED:  

  • Bachelor's degree in Engineering/Natural Sciences or comparable from a four-year college or university required; Master's Degree preferred
  • A minimum of seven years of experience in pharmaceutical/medical device quality roles preferred or a combination of prior education and experience in medical device/pharmaceutical and other ISO regulated organizations
  • Clear understanding of quality system requirements and experience in helping develop and implement quality system initiatives preferred
  • American Society for Quality (CQA, CQBA, CQE, CQM/OE) and/or Regulatory Affairs Professionals Society or comparable certifications are preferred
  • Knowledge of 21 CFR Part 210, 211, 820 as well as ISO 9001 and 13485 preferred


KNOWLEDGE SKILLS & ABILITIES:

  • Working knowledge of Title 21 Code of Federal Regulations and other Federal and State regulations applicable to O&M's private brand products
  • Working knowledge of electronic quality/regulatory software a plus
  • Ability to work independently and as part of a team.  Provide leadership to cross-functional teams and able to drive teams towards successful results.
  • Good verbal and written communication skills; strong interpersonal skills
  • Strong analytical capabilities with demonstrated skill in evaluating reports, identifying issues, noting trends, and reporting to these observations to management
  • Must be able to define problems, collect data, establish facts and draw conclusions
  • Ability to analyze and conclude
  • Ability to motivate and direct the work of teammates in multiple facilities in designated areas of responsibility
  • Effective project manager with ability to handle multiple tasks simultaneously prioritizing appropriately

ADDITIONAL REQUIREMENTS:

  • Ability to travel on a limited basis, up to 10%

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