C. R. Bard, Inc.

Quality Operations Manager

2 weeks ago
Industry / Category
Manufacturing/Medical Device
Job ID
2017-10857
Career Level
experienced
Division
Moncks Corner/BMD
Relocation
Yes
US-SC-Moncks Corner

Summary of Position with General Responsibilities

The Quality Operations Manager is responsible for all in-process quality control functions and QA activities throughout the manufacturing process. This role is responsible for assisting in planning, organizing, coordinating, and leading projects relating to manufacturing process quality in addition to supporting the requirements of the Quality System. The Quality Operations Manager may also function as the Facility's Complaint Handling Coordinator and will be the site QA Manager delegate as needed.

Essential Job Functions

  • Manage and effectively lead quality engineers, lab supervisors and other quality team members as deemed necessary.
  • Hire, train, develop, and manage exempt and non-exempt employees.
  • Ensure effective and meaningful development plans are in place for direct reports.
  • Administer the testing and controlling of raw material, in-process, and finished product quality, assuring compliance with company standards and applicable government regulations.
  • Coordinate / perform customer complaint investigations according to plant and corporate QA guidelines, conduct trending on customer complaints, and effectively communicate to upper management.
  • Coordinate and conduct routine and directed audits as needed to assure compliance with domestic and international regulations, local SOP’s and corporate standards.[i.e. QMS , QSIT, Combination Products, Regulatory requirements; Notified Bodies, etc]
  • Participate / lead quality improvement activities pertaining to customer complaints or adverse quality trends. 
  •  Conduct internal audits and coordinate corrective actions and closure for internal and external audits as necessary.
  • Perform continuous quality control evaluation and trend analysis on product quality issues, resolve quality issues and initiate corrective actions with other departments as required. 
  •  Assist with the preparation and maintenance of department budgets. Maintains comprehensive knowledge of applicable regulatory authority quality and regulatory requirements and their interpretation. 
  •  Facilitate QA/QE support for new product launches to ensure robust development, validation (IQ, OQ, PQ), rollout, and implementation. • Coordinate with Operations and Engineering in developing and implementing projects for improvement of processes / products. • Provide feedback to Operations on opportunities related to quality and/or compliance.
  • Draft appropriate documents to support the Quality systems. Support the document control and project management systems. • Support the vendor qualification/assessment requirements of the facility. 
  •  Make decisions on product/process quality based on evaluations.

Basic Qualifications

 

  • Demonstrated ability to effectively collaborate and partner with all levels of management in corporate and division level sites while maintaining an appropriate assertive style is critical.
  •  Strong knowledge of statistics and quality engineering / failure investigation techniques.
  •  Effective project management, communication, and organizational skills.
  •  Excellent interpersonal skills.

Education and/or Experience

  • B.S. in Science or Engineering field
  •  5+ years quality, compliance and regulatory experience in the medical device industry preferred.
  • Combination product and/or pharmaceutical experience preferred.
  • • 2+ years personnel management experience

Physical Demands

 

  • While performing the duties of this job, the employee is frequently required to stand; walk; use hands or arms (to finger, handle or feel objects, tools, or controls). The employee is occasionally required to sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and talk or hear.
  • The noise level in the work environment is normally quiet to moderate.
  • 100% of day spent indoors.
  • Travel 5-10% maximum (domestic and international)

Work Environment

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