Medical Device Quality Director (CAPA) - Philadelphia, Pennsylvania United States - 21314

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JOB DESCRIPTION

Job #: 21314
Title: Medical Device Quality Director (CAPA)
Job Location: Philadelphia, Pennsylvania - United States
Employment Type:
Salary: contact recruiter for details
Other Compensation: Generous Base Salary plus Bonus!
Employer Will Recruit From: Nationwide
Relocation Paid?: Yes

WHY IS THIS A GREAT OPPORTUNITY?


Medical Device Quality Director (CAPA)

COMPANY:

Fortune 50 Company – manufacturer of Medical Device Products

LOCATION: 

Philadelphia, PA metro area

SALARY:

Generous Base Salary plus Bonus

SUMMARY

The Medical Device Quality Director is responsible for partnering with the Medical Devices and Combination Products (MDCP) Quality Leader in direct support of the MDCP Quality strategy implementation within the corporate Quality Systems & Compliance (QS&C) organization.

The incumbent will be accountable for ensuring that all applicable Medical Device and Combination Product Regulations are incorporated within relevant corporate quality policies (Company Quality Standards) in the incumbent’s area of expertise - Corrective and Preventive Actions (CAPA).

JOB DESCRIPTION

RESPONSIBILITIES

  • Provides technical leadership and serves as Medical Device CAPA Subject Matter Expert (SME) within the corporate Quality Systems & Compliance organization.
  • Actively communicate and collaborate with internal and external partners and across functions and divisions such as Engineering, Regulatory, Site Quality, Operations, and Clinical/Safety etc.
  • Owns the creation and content maintenance of new corporate quality policies (Company Quality Standards) for medical devices/combination products within the CAPA subsystem.
  • Leads gap assessments against new regulations and relevant inspectional observations to ensure necessary corporate policy updates are identified and implemented.
  • Supports global manufacturing sites and provides technical coaching and training on compliant implementation of CAPA and associated feeder systems per 820.100.
  • Supports medical device and combination product technical inspectional readiness activities and regulatory inspection responses as needed.
  • May also direct the activities and work product of device quality consultants.

QUALIFICATIONS

QUALIFICATIONS

  • Bachelor’s Degree in Engineering and twenty (20+) years total progressive work experience in R&D/Engineering and Quality at a global manufacturer of Medical Devices.
  • Twelve (12+) years of Medical Device CAPA Program Development and Leadership experience.
  • Experience creating Medical Device CAPA policies in a corporate quality function across several domestic and international development sites and manufacturing sites.
  • Significant experience performing gap assessments between regulatory requirements, corporate quality policies/standards and records.
  • Expert knowledge of Device Root Cause Analysis techniques and CAPA facilitation techniques
  • Expert Knowledge of Medical Device CAPA governance bodies/review boards.
  • Expert knowledge of 21 CFR Part 820, MDD, MDR and ISO 13485.
  • Track record of leading successful medical device and combination products Quality Systems improvement projects
  • Demonstrated experience authoring responses to device regulatory agencies.
  • Excellent analytical, organizational, communication, and interpersonal skills are required.
  • Corporate level leadership role is desired in addition to experience implementing solutions across multiple global sites.
  • Ability to work independently in a highly matrixed organization.

PREFERRED QUALIFICATIONS

  • Master’s Degree in Engineering or closely related technical field.
  • Some knowledge of Pharmaceutical Regulations is desirable
  • Overall operational and financial acumen, Business and Project Management skills and experience a plus.

 

Education:
University - Bachelor's Degree/3-4 Year Degree