Manager CAPA Post-Market Surveillance

The Manager CAPA & PostMarket Surveillance (Manager) is part of AbbVies Medical Device Center within the Shared Services function (MDCSS).  The Medical Device Center manages quality activities across a variety of medical devices and combination products varying from U.S. Class I to Class III (and international equivalents); the Shared Services function serves in an above plant capacity with core emphasis on Product Life Cycle Management and related ancillary functions.  This positions primary focus is on management of the supporting postmarket processes and reports to the Director Medical Device & Combination Products Shared Services (or equivalent).

The Manager leads a team that processes analyzes and evaluates postmarket data in accordance with EU MDR 2017/745 21 CFR 820 SOR/98282 and other relevant regulations. The Manager provides oversight and tactical assistance to their team to identify and escalate postmarket trends manages the actions to resolve manufacturing and supplier issues (e.g. CAPA) and serves as process owner for PostMarket Surveillance Reporting.  The Manager works crossfunctionally to ensure robust integration of postmarket quality activities with the quality risk management process.

The Manager serves as a key contact and advocate between various internal stakeholders (e.g. Regulatory Affairs Medical Safety Medical Writing PMQA etc.) and drives timely coordination and completion of activities.

Duties & Responsibilities

• CAPAs.  Manage CAPA Review Board (CRB) process for Devices & Combination Products ensuring NCRs/CAPAs/SCARs are opened as appropriate to drive meaningful improvements. Oversee timely completion of NCRs/CAPAs/SCARs using a riskbased approach.
• PostMarket Trends.  Manage Potential Trend Evaluations (or similar) stemming from postmarket data ensuring the team completes investigations in a timely manner.  Use evidencebased information to escalate potential trends for further review.
• PostMarket Reporting.  Manage PostMarket Reporting process (e.g. PMCFP/PMCFR PMSP/PMSR/PSURs PRER CER etc.) providing tactical direction and assistance to internal and external stakeholders.  Maintain process in alignment with current MDCG ISO standards and regulations.
• Quality Audits.  Serve as SME during regulatory inspections in primary areas of responsibility.
• Quality Metrics.  Generate and maintain metrics as requested and use data to drive continuous improvement in assigned functional areas.  Escalate discrepancies and confirmed or potential Quality issues to management.
• Quality Projects.  Propose and lead projects intended to drive meaningful improvements in MDC.  Strive to ensure stateofart processes and systems are developed.
• Team Leadership.  Develop a high performing team ensuring direct reports are given opportunities to learn grow and utilize their strengths.  Ensure team maintains patientcentric focus.

Qualifications :

Qualifications

• Bachelors Degree in a scientific/technical discipline with 8 years of experience in Medical Devices
• People leadership experience
• Working knowledge of EU MDR 2017/745 21 CFR 820
• Direct experience managing CAPAs ( 3 years)
• Direct experience working in the PostMarket space.
• Ability to make sound judgements
• Ability to tailor mentorship and coaching based on staffs individual needs
• Analytical organized with strong attention to detail
• Fluent in verbal and written English

Preferred Qualifications

• Experience with ComplianceWire Global TrackWise Polarion (Siemens) ALM and OneVault
• Working knowledge of relevant MDCG and ISO standards
• Skilled in data analytics and CAPA tools
• ASQ Certification (e.g. CQA CQE) or equivalent

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our shortterm incentive programs. 

• This job is eligible to participate in our longterm incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.

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