Quality Engineering Supervisor Position Available In Cheshire, New Hampshire

Work Location:

Jaffrey, New Hampshire Shift:

No Department:

LS-SC-PEJFA US

Jaffrey QA Admin Hiring Manager:

Gretchen Ingvason This information is for internals only. Please do not share outside of the organization. Your Role We are seeking a motivated Quality Engineering Supervisor to support device manufacturing at the Jaffrey Manufacturing site. This position will manage a small team of Quality Engineers and Quality Technicians and oversee three rapidly growing manufacturing work centers, partnering with Operations, Engineering, Product Management (Marketing) and EHS. The candidate’s ability to apply fundamental engineering techniques and lean/six sigma principles to enhance product performance is crucial to this role. The Supervisor will provide guidance and mentorship to his/her expanding team of quality engineers and quality technicians. In addition to the supervisory requirements, the candidate will also be responsible for providing day-to-day Quality Engineering support for a fast-paced device manufacturing operation, including: Evaluation of out-of-specification conditions and providing guidance for the disposition of non-conforming product and raw materials, Leading quality investigations (RCA and CAPA management) Perform statistical analysis and trending to assess and monitor product/process performance, Working with cross functional teams to set the requirements to support product and process modifications; ensuring that Change Control requirements are met based on internal company procedures and applicable industry standards and regulations Lead and participate in the creation of risk assessments (product and process- FMEA) Participate in product validation and equipment qualifications by establishing acceptance criteria, statistical sampling plans, data analysis, and write validation protocols and reports Create / revise Standard Operating Procedures, Test Methods, and other documents

Who You Are Minimum Qualifications:

Bachelors Degree in Biology, Mechanical Engineering, or other Life Science or Engineering discipline 2+ years of Quality Engineering experience

Preferred Qualifications:

Master’s degree in Biology, Mechanical Engineering, or other Life Science or Engineering discipline Leadership experience in an FDA regulated environment (pharmaceutical, biotechnology, or medical device) 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 action Strong communication skills with the ability to collaborate with Customers and at all levels and functions of the organization. Pragmatic risk-based decision maker with strong problem-solving Collaborative and motivated team player Experience with relevant data analysis software (i.e., Minitab) Working knowledge of Electronic Quality Systems (CAPA, Change Control, Documentation Management) Black Belt or Green 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.