Manager, Medical Device Program (1st shift)

Pfizer-posted 10 months ago

$102,900 - $171,500/Yr

Full-time • Mid Level

Rocky Mount, NC

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The primary responsibility of the position is to act as the Rocky Mount site subject matter expert of regulations specific to medical devices and combination products. This position is responsible for ensuring activities such as change control, design transfer, and CAPA are completed in a manner that is compliant with regulations and procedures. This person will also be the liaison between the plant and the Design Center for all projects and changes related to Medical Device and combination products.

Work as a liaison between the Design Center and Rocky Mount for all Medical Device and Combination Product projects as well as life cycle management of existing products.
Ensure the appropriate application of design control for change control management and Design Transfer.
Ensure the appropriate application of Medical Device risk management principles for Risk File review and pFMEAs activities at the site.
Support Medical Device/Combination Product investigations by applying applicable FDA CAPA requirements.
Act as SME during internal and external inspection related to Medical Device Quality Systems.
Work with all functional areas to understand processes and potential impact to Medical Device/Combination Products when changes are implemented.
Educate all functional areas on the requirements associated with Medical Device and Combination Products.

Bachelor's degree with at least 4 years of experience; OR a Master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR an Associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.
Pharma or Device experience.
Experience in FDA Quality System (21CFR 820 Regulations) and ISO 13485.
Experience in Medical Device Risk Management Activities including ISO 14971.

5 years of experience in Medical Device related fields.
ASQ CQE certification.
Advanced statistical training.
Experience facilitating and coordinating compliant Device CAPA site governance processes.
Experience at a medical device manufacturer in a design quality role.

401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
Paid vacation, holiday and personal days.
Paid caregiver/parental and medical leave.
Health benefits to include medical, prescription drug, dental and vision coverage.

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Manager, Medical Device Program (1st shift)

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