Quality Engineer

Merck•Jaffrey, NH

5d•Onsite

About The Position

We are seeking a motivated Quality Engineer to join our team supporting device manufacturing at the Jaffrey site. This role provides support in ensuring product quality, compliance with cGMP, ISO, and internal Quality Management System (QMS) requirements, and managing investigations within a fast-paced, regulated manufacturing environment.

Requirements

Bachelor’s degree in Engineering, Science, or other technical discipline (e.g., Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Biology, Chemistry, or a similar field).
1+ years of experience in Quality Engineering or other technical role in a regulated manufacturing environment.
Working Knowledge of ISO & FDA regulations (such as ISO 9001, ISO 13485 or 21 CFR 820, 210 & 211).
Demonstrated experience leading quality investigations including root cause analysis and defining corrective/preventative actions.
Strong communication skills with the ability to collaborate with Customers and across all organizational levels
Pragmatic, risk-based decision-maker with strong problem-solving skills.
Collaborative and motivated team player with experience using data analysis tools such as Minitab and working knowledge of Electronic Quality Systems including CAPA, Change Control, and documentation management processes.

Nice To Haves

Master’s degree in Engineering, Science, or other technical discipline (e.g., Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Biology, Chemistry, or a similar field).
2+ years of experience in Quality Engineering or other technical role in a regulated (pharmaceutical, biotechnology, or medical device) manufacturing setting with proven track record of successful performance.
Lean/Six Sigma Green or Black Belt certification and ASQ Certified Quality Engineer (CQE) credentials.

Responsibilities

Provide quality engineering guidance for the disposition of non-conforming products and raw materials using risk based and GMP compliant approaches.
Lead investigations related to internal failures, customer complaints, and process excursions using structured methodologies (e.g., Fishbone, 5 Why); ensure investigations are thorough, timely and drive robust CAPAs.
Lead and/or participate in product/process risk assessments (e.g., FMEA) and partner with cross-functional teams to resolve quality issues impacting filter production yield, and customer delivery.
Provide guidance and support for product and process changes by collaborating with the cross-functional team ensuring changes are risk based, documented, and implemented in compliance with internal procedures and applicable industry standards and regulations.
Provide guidance for product validation and equipment qualifications by establishing acceptance criteria, statistical sampling plans, performing data analysis, and reviewing validation protocols and reports
Create or revise Standard Operating Procedures, Test Methods and other documents.
Perform statistical analysis and trending to assess and monitor product or process performance.
Provide guidance and support for shelf-life studies both accelerated and real-time aging, including protocol creation, data analysis, out of specification investigation, and report creation.