Shire Device Quality Regulatory Compliance Engineer (Manager level) in Lexington, Massachusetts

Primary Duties

This role will provide comprehensive support and compliance monitoring for Medical Devices and Combination products to all applicable regulations but not limited to: 21 CFR 4, 820&803, ISO13485 & 14971, MDD/MDR, IVDD/IVDR, CMDCAS, Australia, Japan etc…

cGMP compliance for Device Combination Products(DCP) QMS including processes but not limited to Management Review, Measurement, Analysis, Improvements, Post Market activities, Product Vigilance, Clinical Evidence, DMR, Customer Focus, Product Realization, CAPA and Risk Management.

Interfaces with and provides guidance to cross functional stakeholders on matters pertaining to Device Quality Assurance activities, DCP Compliance, Regulatory Compliance.

Responsibilities

30%: Assures functionality and maintenance of the certified DCP QM system in compliance with applicable regulations and standards. Ensures that all processes needed for the QM system are maintained and inspection readiness is maintained.

20%: Support for other quality systems processes including but not limited to

  • Customer complaints,

  • Incident management,

  • CAPA

  • Deviation

  • Change control support

  • Supplier Quality Management

15%: Support for management review process in compliance with applicable regulations and standards.

15%: Coordination and support for DCP post market activities, vigilance activities and/or clinical evidence as required per market.

10%: Influences QMS strategy to enhance and execute sustainable Device Quality support for internal and external manufacturing, packaging, testing and release of device and combination products. Launch activities.

10%: Participates in ongoing Quality initiatives, Integration support and Operational Excellence.

Education and Experience Requirements

Essential:

  • Bachelor’s Degree in Engineering, Natural Science and/or Medical Degree or equivalent technical discipline required,

  • At least 5 years of experience working with medical devices and/or combination products in a regulated healthcare industry, with a minimum of 3 years in Quality Assurance/Engineering

  • Knowledge of international regulations for Device and Combination Products particularly Medical Device Directive 93/42/EEC, US 21 CFR Part 4, 820, 803, ISO 13485, ISO 14971 and ISO 15223.

  • Experience with Class I & II & III sterile and non-sterile medical devices;

  • Experience interacting and collaborating with cross-functional global teams;

  • Experience working with external manufacturing partners;

  • Strong operations background to ensure value added and effective quality operations;

Desired:

  • Advanced Degree;

  • Experience working in a post-market quality support function preferred

  • Knowledge of in-vitro diagnostics

  • Experience assessing root cause analysis and effective investigation practices;

  • Understanding of GDPs and global supply and distribution networks.

Other Requirements

International travel up to 15% for business meetings with local staff, Inspection support, corporate peers/collaborators, Contract Manufacturing Qualifications and to stay current with professional development opportunities.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.