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Principal Quality Engineer
A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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.
MilliporeSigma is seeking a Principal Quality Engineer to lead and/or participate in quality improvement project teams across a variety of operational departments to identify and implement significant improvements to quality systems and business processes. They will work independently or with cross-functional teams to implement new ways of working to improve quality and compliance; Utilize variety of quality improvement and Six Sigma DMAIC tools; Perform data and trend analysis, reports metrics to site and global management; Provide support for regulatory inspections; Lead and/or participate in trend or other critical impact investigations; Lead projects related to mitigation of risks highlighted on the Risk Register.
- Guides the successful completion of major programs and projects and may function in a project leadership role.
- Provides management with review opportunities at key points and upon completion of projects.
- Ensures quality conduct of projects, including design, data summary and interpretation, report and manuscript preparation and review adherence to applicable regulations.
- Decisions, recommendations and results further the achievement of goals critical to organizational objectives.
- Implements and communicates the strategic and technical direction for the product/project team.
- Identifies any issues that may delay product or project and recommends appropriate action to be taken.
Who You Are:
- Degree in Science, engineering, or technical discipline, PhD preferred.
- or equivalent combination of experience and education.
- 10+ years of experience developing, implementing, or maintaining Quality Management systems in an FDA regulated industry (drugs, biologics, medical devices, or related industry)
- Strong knowledge of Science and Engineering, including technical documentation, with a strong business acumen.
- Extensive knowledge of applicable regulatory, Corporate and/or Unit requirements.
- Regulations and standards such as; 21 CFR 210/211, 21 CFR 600/601/610, 21 CFR 820, ISO 13485, ISO 9001, or similar standards/regulations.
- Professional certification (Lean Six Sigma, ASQ - CQE, CQA, or similar).
- Excellent procedure writing and verbal communication skills.
- Demonstrates good written and oral interpersonal skills.
- Detail oriented with strong analytical and problem-solving skills.
- Ability to work independently as a leader or individual contributor.
- Strong organizational skills.
- Strong computer skills including experience with Microsoft Office applications and database software.
- Demonstrates the ability to effectively manage and prioritize multiple projects and tasks of advanced complexity and duration.
- Project management experience a plus.
- Experience with multi-national corporations a plus.
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.