Heads of Quality

Posted 05 Mar 2024

Stoneham, Massachusetts - United States

Req Id 272771

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Job Title: Heads of Quality

 

Employer: EMD Millipore Corporation

 

Job Location: 85 Maple Street, Stoneham, MA 02180

 

Telecommuting is available for this position. Approximately 20% travel is required per year (10% domestic; 10% international).

 

This position is eligible for the EMD Millipore Corporation Employee Referral Program.

                                                           

Job Duties:

 

The Head of Quality will develop and oversee the site Quality Management System. Specific duties include:

 

  1. Ensure quality strategies and processes are in place to meet internal and external regulatory requirements, business objectives and operational needs;
  2. Drive any necessary quality process change and improvement to deliver quality goals and objectives;
  3. Conduct Risk Assessments to enhance prevention vs correction;
  4. Determine quality KPIs and monitor ongoing progress and performance in a timely manner;
  5. Ensure strong communication between engineering, production and quality teams to facilitate the exchange of nonconformance information in order to implement change and improvements;
  6. Conduct annual Management Review Meetings and coordinate QMS audits;
  7. Oversee and manage key Quality Systems processes;
  8. Investigate, collect, review, and analyze quality-related data; and
  9. Assume ownership of site-level QMS tools and training.

 

Requirements:

 

Employer requires a Bachelor’s degree in Engineering and four (4) years of experience as a Quality Engineer (or related occupation) leading quality systems for a manufacturing facility. A candidate must also hold certificates in Quality Systems Auditing (such as ISO 9001) and Quality Management Systems (such as ISO 9001:2015). In addition, the employer requires the following:

 

  1. Demonstrated ability performing risk assessments, process validations, and process mapping gained through four (4) years of work experience.
  2. Demonstrated experience working with the following regulatory guidelines: Good Manufacturing Practices (GMP), Good Documentation practices (GDP), and 21 CFR part 11 gained through four (4) years of work experience.
  3. Demonstrated ability performing supplier quality management in a regulated industry gained through four (4) years of work experience.
  4. Demonstrated ability performing quality systems audits gained through four (4) years of work experience.
  5. Demonstrated ability overseeing product batch releases gained through four (4) years of work experience.

In the alternative, Employer will accept a Master’s degree in Engineering and two (2) years of experience as a Quality Engineer (or related occupation) leading quality systems for a manufacturing facility. A candidate must also hold certificates in Quality Systems Auditing (such as ISO 9001) and Quality Management Systems (such as ISO 9001:2015). In addition, the employer requires the following:

 

  1. Demonstrated ability performing risk assessments, process validations, and process mapping gained through two (2) years of work experience.
  2. Demonstrated experience working with the following regulatory guidelines: Good Manufacturing Practices (GMP), Good Documentation practices (GDP), and 21 CFR part 11 gained through two (2) years of work experience.
  3. Demonstrated ability performing supplier quality management in a regulated industry gained through two (2) years of work experience.
  4. Demonstrated ability performing quality systems audits gained through two (2) years of work experience.
  5. Demonstrated ability overseeing product batch releases gained through two (2) years of work experience.

All years of experience may be gained concurrently.

 

Applicants can mail resumes to EMD Millipore Corporation., 400 Summit Drive, Burlington, Massachusetts 01803 (Attn: req# 272771 ) or apply online at https://www.emdgroup.com/en/careers/job-search.html.

 



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