DirectJobHub
Jobs · Quality Assurance · Connecticut

Supplier Quality Engineer II

CooperSurgical · Trumbull, CT · 1 wk ago
On-siteQuality Assurance$80k–$100k/yrFull-time

About CooperSurgical

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions.

Work location: Trumbull, CT or Livingston, NJ (on-site)

About the Role

The Supplier Quality Engineer II is responsible for supporting all functions of the Global Supplier Quality Program and ensuring consistency in compliance with regulatory requirements and corporate standards. This role ensures all quality standards are met by suppliers to CooperSurgical.

Responsibilities

  • Lead SCAR, SCN, and Supplier Nonconformance processes, Supplier Development activities, and Risk Assessments.
  • Manage Supplier Quality sustaining activities, including:
    • Facilitate the supplier compliance program (site audits, drive improvement in supplier performance, supplier development, supplier selection, and qualification).
    • Act as a quality assurance consultant in the development and implementation of quality systems in compliance with FDA QSR, ISO 13485, MDD, CMDCAS, and other relevant requirements at partner suppliers/vendors.
  • Work with Value Streams, Engineering, and Quality Engineering to confirm Supplier-related improvement opportunities or Non-Conforming Material Reports (NCMRs).
  • Support development and implementation of the supplier quality program by:
    • Managing the supplier on-going monitoring and re-evaluation process.
    • Managing Supplier SCAR / CAPA / NCR and periodically providing metrics/reports to the Management Review Process.
    • Creating and maintaining supplier quality agreements.
  • Support all Procurement supplier projects, new product development intended for production at suppliers, and business continuity projects at suppliers.
  • Update SOPs and Forms related to the supplier management process as needed.
  • Support internal and external QMS audits and serve as a key player in audit backup or inspection rooms.
  • File and maintain Supplier-related documentation as per QMS.
  • Perform supplier audits and conduct supplier site visits to identify systemic gaps in performance expectations and implement mitigating processes at Cooper sites.
  • Collaborate with Quality Engineers, Inspectors, Value Streams, and Purchasing teams.
  • Submit Supplier Corrective Action Requests (SCAR) for Supplier-related NCMRs and review supplier responses for appropriate root-cause analysis and corrective actions.
  • Support supplier validation activities, transfer projects, and supplier localization projects from a Supplier Quality perspective.
  • Support IQ, OQ, PQ, and PPAP processes.
  • Perform other duties as assigned.

Travel: This position may require 10-25% domestic and/or international travel.

Requirements

  • Bachelor’s Degree in Chemical, Electro-Mechanical, Industrial, Bioprocess Engineering, or a related Life Science field, or equivalent experience/skillset.
  • 3+ years in a regulated quality environment.
  • 3+ years working with Supplier Management processes.

Skills

  • Knowledge of FDA QSR, ISO 13485, EUMDR, ISO 14971.
  • Experience with regulated Supplier Management processes.
  • Experience in supply chain, auditing, verification, validation, and GD&T.
  • Experience with Change Control Systems, FDA QSRs, ISO 13485, and Design Control.
  • Experience negotiating with suppliers.
  • Excellent verbal and written communication skills and strong organizational skills.
  • Proficiency in MS Office, Minitab, and experience with ERP and QMS systems.
  • Understanding of relevant processes and cost drivers per market, commodity, or segment.

CQE, APICS, Green Belt, or Black Belt certifications are a plus.

Work Environment

Production/Clean Room/Warehouse/Office environment which may require long periods of sitting, standing, or getting up and down throughout the day.

Benefits

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan, including:

  • Medical coverage.
  • 401(k) retirement plan.
  • Parental leave and fertility benefits.
  • Paid time off for vacation, personal, sick, and holidays.
  • Multiple other perks and benefits.

Pay

The starting base pay for this role is between $80,000.00 - $100,000.00 annually. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.

Similar jobs