Quality Systems Engineer 1
MilliporeSigma

Job Info

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A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

Your Role:

At MilliporeSigma, the Quality SystemsEngineershall be responsible for the site's Data Integrity Compliance and the Quality Management System (QMS) Audit Program reporting to the Quality Systems Manager.

• Coordinate Data Integrity activities at the site by collaborating with operational teams to complete assessments and implement mitigation actions.
• Manage the Data Integrity Master Plan including gap assessments, migration plans, and data life cycle maintenance while ensuring Data Integrity Life Cycle is embedded in the site's culture.
• Establish and maintain a list of certified Data Integrity SME's.
• Report data integrity status in the LS Heat Map and periodically to site leadership.
• Support and serve as alternate to the Quality Management System audit and compliance programs for the Jaffrey, NH manufacturing site.
• Serve as alternate to host customer, regulatory and internal QMS audits for the Jaffrey, NH site.
• Complete certified lead auditor training, to assist in the Management of the Jaffrey internal audit program.
• Generate formal audit responses and correspondences, initiating CAPAs, reporting audit trends and analysis while promoting compliance best practices.
• Lead and perform validation activities related to the sites' product labeling processes.
• Serve as a sterilization Subject Matter Expert for the sites' product Gamma Irradiation processing.
• Monitor assigned actions to assure the audit findings are satisfied.
• Act as subject matter expert for ISO 9001:2015 principles and FDA Quality System Regulation 21 CFR Part 820

Who You Are:

BasicQualifications:

• Bachelor's Degree in Mechanical, Biomechanical, Biomedical, Quality, Chemical Engineering, or related life science discipline
• Experiencein customer or regulatory agency and internal QMS compliance audit programs is required

Preferred Qualifications:

• 3+years in a FDA regulated industry (pharmaceutical, biotechnology or medical device)
• Working knowledge of CAPA and Change Control systems
• Self-directed and self-motivated
• Ability to lead high level site tours with customers and internal teams
• Lean Six Sigma certification a plus
• Certified Lead Auditor, ASQ Certified Quality Auditor (CQA)
• Communication skills, both written and oral, with the ability to collaborate at all levels and functions of the organization and with customers.
• Experience gaining consensus with groups
• Comprehensive understanding and application of Quality Management Systems in the Life Science industry, relative to ISO 9001:2015 principles.

RSRMS

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Job Requisition ID: 230205

Location: Jaffrey

Career Level: C - Professional (1-3 years)

Working time model: full-time

This job has expired.