Work Location: Jaffrey, New Hampshire
Shift:
Department: LS-SC-PEJF Quality Jaffrey
Hiring Manager: Fuad T Ashour
This information is for internals only. Please do not share outside of the organization.
Your Role
We are seeking a talented Quality Engineer to join our team, supporting New Product Introduction at our Jaffrey, NH location. The Jaffrey Manufacturing Center of Excellence is a world-class facility, ISO 9001 and ISO 14001 certified, and committed to Six Sigma principles. With a strong focus on environmental responsibility and long-term sustainability, it is a leading example of operational excellence.
- Collaborate with Product Development and Product Management teams to introduce new products and/or line extensions into the Jaffrey facility.
- Act as a liaison between product development and the plant, providing guidance and support for device manufacturing.
- Lead and participate in the creation of risk assessments, including product and process FMEAs (Failure Modes and Effects Analysis).
- 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, ensuring compliance with regulatory standards.
- Create and revise Standard Operating Procedures (SOPs), test methods, and other related documents.
- Perform statistical analysis and trending to assess and monitor product and process performance.
- Offer guidance for the disposition of non-conforming products and raw materials, including evaluating deviations/out-of-specification conditions, trending data, and leading quality investigations (root cause analysis and corrective action plans).
- Support 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
Minimum Qualifications:
- Bachelor of Science degree in Engineering (Chemical, Mechanical, or other Engineering discipline).
- 3+ years Quality Engineering experience in a manufacturing environment.
Preferred Qualifications:
- Master’s degree in Engineering (Chemical, Mechanical, or other Engineering discipline).
- Knowledge in ISO 9001:2015.
- 5+ years Quality Engineering experience in manufacturing; experience in an FDA regulated (pharmaceutical, biotechnology, or medical device) environment.
- 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.
- Validation experience in a regulated manufacturing industry.
- Conduct quality investigations including root cause analysis and determining corrective / preventative actions, pragmatic risk-based decision maker with strong problem-solving skills.
- Demonstrated ability to create and update standard operating procedures.
- Collaborative and motivated team player.
- Experience with relevant data analysis Software / Tools (Minitab) and Methods, working knowledge of Electronic Quality Systems (CAPA, Change Control, Documentation Management).
- ASQ CQE, Six Sigma 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.