Quality Engineers II
Millipore Corporation

Job Info

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Work Location: Jaffrey, New Hampshire
Shift: No
Department: LS-SC-PEJFBA DSP Quality Engineer Lead (01081433)
Recruiter: Ashley Hennessy

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

NOTICE OF FILING

This notice is posted as the result of the filing of an Application for Alien Labor Certification with the Department of Labor for the job opportunity listed below. Any person may provide documentary evidence bearing on this Labor Certification Application to Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue NW, Room N-5311, Washington, DC 20210.

Employer: EMD Millipore Corporation

400 Summit Drive

Burlington, Massachusetts 01803

Job Site: 11 Prescott Road

Jaffrey, New Hampshire 03452

Position: Quality Engineers II

Job Duties:

The Quality Engineer II will evaluate deviations and out-of-specification conditions and data trends and conduct quality investigations by performing root cause analyses, developing

corrective action plans, and researching issues related to customer quality complaints. Specific job duties include: 1. Provide mentorship and support for device manufacturing, including evaluation of deviations and out of specification conditions, data trending, and leading quality investigations, with a particular focus on root cause analysis, corrective action plans, and customer complaints; 2. Drive product and process changes by working with the cross-functional team to determine the implementation requirements based on applicable industry standards and regulations; 3. Assist with product validation and equipment qualifications including establishing acceptance criteria, sampling plans, and performing data analysis; 4. Write and approve validation protocols and reports; 5. Create and revise Standard Operating Procedures, Test Methods, and other documents; 6. Maintain compliance to ISO 9001 and QSR (cGMP) for medical devices in the department's functions and responsibilities; 7. Perform statistical analysis and trending to assess and monitor product or process performance; 8. Approve the disposition of non-conforming products and raw materials; 9. Lead and participate in the creation of risk assessments (e.g., design and process FMEA); and 10. Provide guidance and support for shelf-life studies in relation to both accelerated and real-time aging, including protocol creation, sample submission, data analysis, out-of-specification investigation, and report creation. Salary: ninety-seven thousand six hundred twenty-four dollars and zero cents to one hundred seventeen thousand six hundred twenty-four dollars and zero cents per year.

Requirements:

Employer requires a bachelor's degree in mechanical engineering, industrial engineering, or a closely related field and three (3) years of work experience as a Quality Engineer or a closely

related occupation. In addition, employer requires: 1. Demonstrated ability utilizing an electronic quality management system (QMS) to coordinate and direct an organization's activities to meet customer, regulatory, and internal requirements gained through two (2) years of work experience; 2. Demonstrated ability utilizing process mapping and Fishbone analysis to conduct quality investigations including determining corrective and preventive actions (CAPA) gained through two (2) years of work experience; 3. Demonstrated ability utilizing waterfall project management approaches to perform Product Qualification and Equipment Validation by defining process specifications, creating procedural documents, batch records & test method updates, and authoring & reviewing IQ/OQ/PQ protocols and reports gained through two (2) years of work experience; 4. Demonstrated ability collaborating with internal stakeholders at all levels and functions and with customers gained through two (2) years of work experience; and 5. Demonstrated ability performing data and statistical analysis using software such as Excel and Minitab and visualization tools such as MS PowerBI gained through two (2) years of work experience. All years of experience may be gained concurrently.

Applicants can send resume to EMD Millipore Corporation., 400 Summit Drive, Burlington, MA 01803 (Attn: Req.#281323) or apply online at https://careers.emdgroup.com

DATE POSTED: ______________________ DATE REMOVED: ___________________

LOCATION POSTED: _________________________________________________________

EMPLOYER SIGNATURE: ______________________________________________________

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.

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