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TFF Quality Engineer
A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 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 looking for an experienced Quality Engineer to join our team supporting Tangential Flow Filtration (TFF) device manufacturing in Jaffrey, NH. The world-class Jaffrey Manufacturing Center of Excellence is ISO 9001 and ISO 14001 Certified, practices Six Sigma principles and is an environmentally conscious facility focused on long term sustainability.
- Provide guidance and support for TFF device manufacturing. This includes the evaluation of deviations / out of specification conditions, data trending, and leading quality investigations: root cause analysis, corrective action plans and customer complaints.
- Provide guidance and support for product and process changes by working with the cross-functional team to determine the implantation requirements based on applicable industry standards and regulations.
- Provide guidance and support for product validation and equipment qualifications including establishing acceptance criteria, sampling plans and performing data analysis.
- Write or approve validation protocols and reports.
- Create or revise Standard Operating Procedures, Test Methods and other documents.
- Maintains compliance to ISO 9001 and QSR (cGMP) for medical devices in the department functions and responsibilities.
- Perform statistical analysis and trending to assess and monitor product or process performance.
- Provide guidance and approve the disposition of non-conforming product and raw materials.
- Lead and participate in the creation of risk assessments (e.g. design and process FMEA).
- Provide guidance and support for shelf life studies both accelerated and real-time aging, including protocol creation, sample submission, data analysis, out of specification investigation, and report creation.
Who you are:
- BS degree in a scientific/technical discipline – Engineering preferred.
- 3+ years Quality Engineering experience in a FDA regulated (pharmaceutical, biotechnology, or medical device) manufacturing setting with proven track record of successful performance.
- Understanding or experience with ISO & FDA regulations (such as ISO 9001, ISO 13485 or 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").
- Demonstrated validation experience in a regulated manufacturing industry.
- Strong communication skills with the ability to collaborate at all levels and functions of the organization and with customers.
- Ability to operate in a complex, matrixed, and fast-paced environment and gain consensus with groups is a must.
- 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)
- Advanced degree, MS or MBA, a plus.
- ASQ CQE a plus
- Green Belt or Black Belt a plus
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.