Quality Engineer I
This is a Quality Engineering position supporting device manufacturing in the Jaffrey NH facility.
· 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 and corrective action plans).
· 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 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 non-conforming product and raw materials.
· Lead and participate in the creation of risk assessments (product 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.
· 0-2 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 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').
· Ability to operate in a complex, matrixed, and fast paced environment and gain consensus with groups is a must
· Experience with relevant data analysis Software / Tools (Minitab) and Methods
· Advanced degree (MS of MBA) a plus.
· Black Belt or Green Belt a plus
· Working knowledge of Electronic Quality Systems (CAPA, Change Control, Documentation Management)
· Have strong communication skills with the ability to collaborate at all levels and functions of the organization and with customers.
· Pragmatic risk-based decision maker with strong problem solving ability.
· Collaborative and motivated team player. Always looking to share and advance best practices.
Job Requisition ID: 202919
Career Level: C - Professional (1-3 years)
Working time model: full-time
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.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.
Nearest Major Market: Bellows Falls
Nearest Secondary Market: Keene
Job Segment: Biotech, Medical, CAPA, Pharmaceutical, Quality, Science, Healthcare, Management