A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 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.
We are seeking a talented Quality Engineering Supervisor to support device manufacturing at the Jaffrey Manufacturing site. This position interfaces with manufacturing, Engineering, Product Management (Marketing) and EHS. Your ability to apply fundamental engineering techniques and lean/six sigma principles to enhance product performance is crucial to this role. You will also be responsible for leading a small team of quality engineers and quality technicians.
The candidate will be responsible for leading a small team of quality engineers and quality technicians, providing guidance and mentorship to his/her direct reports. In addition to the supervisory requirements, the candidate will also be responsible for providing day to day Quality Engineering support for a fast pace device manufacturing operation. This includes the evaluation of deviations / out of specification conditions, data trending, and leading quality investigations (root cause analysis and implementation of corrective action plans), perform statistical analysis and trending to assess and monitor product/process performance, provide guidance for the disposition of non-conforming product and raw materials, lead and participate in the creation of risk assessments (product and process- FMEA). The candidate will also be responsible for assessing and setting the requirements to support product and process modifications by working with cross functional teams; ensuring that implementation requirements are met based on internal company procedures and applicable industry standards and regulations. The candidate will provide guidance and support for product validation and equipment qualifications including establishing acceptance criteria, statistical sampling plans, performing data analysis, and write validation protocols and reports. The candidate will create / revise Standard Operating procedures, Test Methods and other documents. The candidate will also provide guidance and support for shelf life studies both accelerated and real-time aging including protocol and report creation, sample submission, data analysis, out of specification investigation.
Who You Are:
- BS degree in a scientific/technical discipline
- 5+ years of Quality Engineering experience
- 2+ years leadership experience in an FDA regulated (pharmaceutical, biotechnology, or medical device)
- BS degree in Engineering preferred
- Understanding or experience with ISO & FDA regulations (such as 21 CFR 820, 210 & 211).
- Demonstrated ability to conduct quality investigations including root cause analysis and determining corrective / preventative actions.
- Demonstrated ability to create and update standard operating procedures ("SOP").
- Have strong communication skills with the ability to collaborate at all levels and functions of the organization and with customers.
- Pragmatic risk-based decision maker with strong problem-solving ability.
- Collaborative and motivated team player. Always looking to share and advance best practices.
- Experience with relevant data analysis Software / Tools (Minitab) and Methods
- Working knowledge of Electronic Quality Systems (CAPA, Change Control, Documentation Management)
- Black Belt or Green Belt 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.