Job description

Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
Your role:
We are looking for a Quality Engineer to join our team supporting membrane manufacturing and device assembly in Jaffrey, NH. The world-class Jaffrey Manufacturing Center of Excellence is ISO 9001 and ISO 14001 Certified, practices Six Sigma principles and is an environmentally conscious facility focused on long term sustainability.

• 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 implantation 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 (e.g., 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.
• A Shift: Monday - Friday 8AM - 5PM

Who you are:
Minimum Qualifications:

• Bachelor of Science Degree in Engineering
• 1+ years Quality Engineering experience in a FDA regulated (pharmaceutical, biotechnology, or medical device) environment

Preferred Qualifications:

• 3+ years Quality Engineering experience in a FDA regulated (pharmaceutical, biotechnology, or medical device) environment
• Master's degree or MBA
• Knowledge in ISO & FDA regulations (such as 21 CFR 820, 210 & 211).
• Ability to conduct quality investigations including root cause analysis and determining corrective / preventative actions, Pragmatic risk-based decision maker with strong problem-solving ability.
• Demonstrated ability to create and update standard operating procedures ("SOP"),
• Validation experience in a regulated manufacturing industry.
• 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
• Collaborative and motivated team player. Always looking to share and advance best practices.
• Experience with relevant data analysis Software / Tools (Minitab) and Methods, working knowledge of Electronic Quality Systems (CAPA, Change Control, Documentation Management)
• ASQ CQE, Green Belt or Black Belt

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

Job Type: Full-time

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