Quality Engineer 2 at Millipore Corporation in Peterborough, New Hampshire

Job Description:

Work Location: Jaffrey, New Hampshire
Shift: No
Department: LS-SC-PEJFBA DSP Quality Engineer Lead
Hiring Manager: Muhammad Ali Shah



This information is for internals only. Please do not share outside of the organization.




Your Role

• Provide guidance and support for 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 implementation 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 daily quality review board meetings of assigned area.


• Lead and participate in the creation of risk assessments (e.g. design and process FMEA).


• Lead projects with cross functional teams to improve in-process quality, reduce customer complaints, and increase production efficiency


• 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

A Shift: Monday - Friday 8AM - 5PM



Who you are:




Minimum Qualifications:

• Bachelor's of Science degree in Engineering, Biology, or Chemistry.


• 2+ years manufacturing or Quality experience in an FDA regulated (pharmaceutical, biotechnology, or medical device) environment

Preferred Qualifications:

• 5+ years of Quality Engineering experience in a FDA regulated (pharmaceutical, biotechnology, or medical device) manufacturing setting with proven track record of successful performance.


• Experience with ISO & FDA regulations (such as ISO 9001, ISO 13485 or 21 CFR 820, 210 & 211).


• 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.


• Conduct quality investigations including root cause analysis and determining corrective / preventative actions.


• Collaborative and motivated team player.


• Perform job duties with minimal oversight and guidance


• Pragmatic risk-based decision maker with strong problem-solving ability.


• Experience with relevant data analysis software tools (Minitab) and methods


• Working knowledge of Electronic Quality Systems (CAPA, Change Control, Documentation Management).


• MS in Engineering, Biology, or Chemistry.


• ASQ CQE.


• Green Belt or Black Belt.

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. Apply Now