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Senior Quality Engineer, Global Contract Manufacturing

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Date: Jun 22, 2022

Location: Libertyville, IL, US

Company: Hollister Incorporated

We Make Life More Rewarding and Dignified

Location: Libertyville 
Department: Quality 

Summary:

 

Support the Global Contract manufacturing (GCM) virtual manufacturing facility in assuring quality products for Hollister’s customers. The Sr. Quality Engineer role includes operating as a core member (or leader) of project teams for new product development and change implementation. Evaluate and manage contract manufacturers, provide assistance by identifying quality improvement initiatives and cost savings. Address quality concerns for current products, development opportunities, and process improvements that positively impact GCM product quality and the Hollister Quality Management System.  Partner with the cross-functional team members to achieve GCM and Global Quality objectives compatible with Hollister Mission and Vision.

 

Responsibilities:

  • Drive Supplier selection and evaluation process of Contract Manufacturers. Execute quality agreements, and perform audits as part of supplier management; ensure compliance with relevant quality system regulations.
  • Act as primary quality contact with finished good suppliers, working with them to solve issues that arise and recommend improvements. 
  • Monitor supplier quality performance metrics and drive resulting corrective/preventive actions
  • Actively help maintain and improve a Quality System compliant with FDA regulations and ISO 13485 Assist in any external regulatory audits.
  • Interface with internal cross-functional partners on new product development and significant changes related to GCM finished goods and processes. Support development and maintenance of Design History File (DHF), Technical Files, and Device Master Record (DMR).
  • Liaise between Hollister and the Supplier during project execution. Implement product/process changes, and drive successful design transfer.
  • Coordinate process qualification activities where appropriate, to ensure that quality controls are maintained.
  • Contribute to or lead Risk Management activities with suppliers, including but not limited to risk assessment, DFMEA, PFMEA.
  • Review Device History Records (DHR) to support release of finished goods from Contract Manufacturers to distribution centers.
  • Partner with Operations and Engineering to identify and implement cost savings opportunities.
  • Develop specifications, bill of materials (BOM), and other documentation as needed.

 

Requirements:

  • Bachelor's degree is required; Engineering, Science or related study is preferred
  • 8-12 years overall experience is required for a Sr. Quality Engineer.
    • May consider the right applicant for a Quality Engineer with under 8 years’ experience.
  • Minimum of 5 years’ experience in a Quality Engineering (or equivalent industry discipline) required.
  • Experience in Medical Device Manufacturing in compliance with applicable foreign and domestic regulations including US FDA 21 CFR Part 820, ISO 13485, EU Medical Device Regulation.
  • ASQ Certified Quality Engineer certification is preferred.
  • ASQ Certified Quality Auditor or Recognized Lead Auditor Certification Program is preferred.
  • Strong understanding of statistical analysis methods (e.g., ANOVA, process capability analysis, DOE, GR&R, etc.). 
  • Knowledge and experience in statistical software packages (e.g., Minitab) for data analysis.
  • Basic technical writing skills required, advanced technical writing skills preferred.
  • Ability to interface with a computer for long periods of time.
  • Must be able to manage some occasional light lifting, sitting prolonged periods of time (6-8 hrs).
  • Good communication skills, both written and oral, to an international supply base with varied cultural expectations.
  • English proficiency.
  • Ability to travel domestically/internationally 20-30%.

 

Our Total Rewards package in aggregate is above market and includes competitive pay, generous paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, generous retirement savings, and a unique Benefit of Employee Share Ownership Program (BESOP).

 

Hollister Incorporated is an independent, employee-owned company that develops,manufactures, and markets healthcare products worldwide. The company develops and manufactures products for ostomy care, continence care and critical care, and also develops educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, it has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider Inc (JDS Inc), a 100 year old company. Hollister is guided by the shared Mission of JDS Inc, to make life more rewarding and dignified for people who use its products and services.  www.Hollister.com 

Hollister is an EO employer – M/F/Veteran/Disability


Job Req ID: 30478


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