Quality Engineer I
Quality Engineer I
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
A career with MilliporeSigma is an ongoing journey of discovery: our 57000 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.
Your role
We are looking for a Quality Engineer to join our team supporting new product introductionin Jaffrey NH. The worldclass 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 devic manufacturing. This includes the evaluation of deviations / out of specification conditions data trending and leading quality investigations (root cause analysis and corrective action plans).
- 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 validation protocols and reports.
- Create / Revise Standard Operating Procedures Test Methods and other documents.
- Perform statistical analysis and trending to assess and monitor product/process performance.
- Provide guidance for the disposition of nonconforming product and raw materials.
- Lead and participate in the creation of risk assessments (e.g. product and processFMEA).
- Provide guidance and support for shelf life studies both accelerated and realtime aging. Including protocol creation sample submission data analysis out of specification investigation and report creation.
Who you are
Minimum Qualifications:
- Bachelor of Science degree in Engineering or Technical Degree
- 1 years Quality Engineering experience in a FDA regulated (pharmaceutical biotechnology or medical device) environment
Preferred Qualifications:
- 3 years Quality Engineering experience in a FDA regulated (pharmaceutical biotechnology or medical device) environment
- Masters degree or MBA
- Knowledge in ISO & FDA regulations (such as 21 CFR 820 210 & 211.
- Ability to conduct quality investigations including root cause analysis and determining corrective / preventative actions pragmatic riskbased decision maker with strong problemsolving ability.
- Demonstrated ability to create and update standard operating procedures (SOP)
- 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 operate in a complex matrixed and fast paced environment and gain consensus with groups
- 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)
- ASQ CQE Green Belt or Black Belt
RSRMS
RSR
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
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.
Employment Type
Full Time
