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Position: Quality Engineers II

Employer:      EMD Millipore Corporation                          

400 Summit Drive

Burlington, Massachusetts 01803

Job Site:         11 Prescott Road

Jaffrey, New Hampshire 03452

Responsibilities:

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.

Requirements & Qualifications:

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.

This position is eligible for the EMD Millipore Corporation Employee Referral Program.

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

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html