Quality Engineer 1

Merck•Jaffrey, NH

4d•Onsite

About The Position

This role is critical in ensuring product quality, process compliance, and managing investigations within a fast-paced, regulated manufacturing environment. Provide guidance and support for device manufacturing and quality control testing, including evaluating deviations/out-of-specification conditions, data trending, and leading quality investigations such as root cause analysis and corrective action plans. Collaborate with cross-functional teams to support product and process changes, determining implementation requirements based on applicable industry standards and regulations. Guide and support product validation and equipment qualifications, including establishing acceptance criteria, sampling plans, and performing data analysis. Write or approve validation protocols and reports. Create or revise Standard Operating Procedures (SOPs), Test Methods, and other quality-related documents. Maintain compliance with ISO 9001 and QSR (cGMP) for medical devices within departmental functions and responsibilities. Perform statistical analysis and trending to assess and monitor product or process performance. Lead cross-functional quality initiatives by managing non-conforming product dispositions, conducting risk assessments (design and process FMEAs), supporting shelf-life studies, and driving improvements in product quality, customer satisfaction, and operational efficiency.

Requirements

Bachelor’s degree in Engineering (Biomedical, Mechanical, etc.) or Life Science (Biology, Chemistry, etc.)
1+ years of experience in Quality Engineering or other technical roles in a regulated manufacturing environment.
External applicants must be eligible to work in the US.
This role does not offer sponsorship for work authorization.

Nice To Haves

3+ years of Quality Engineering experience in an FDA-regulated (pharmaceutical, biotechnology, or medical device) manufacturing setting with a proven track record of successful performance.
Understanding or experience with ISO & FDA regulations (such as ISO 9001, ISO 13485, or 21 CFR 820, 210 & 211).
Demonstrated ability to create and update Standard Operating Procedures (SOPs).
Demonstrated 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.
Demonstrated ability to operate in a complex, matrixed, and fast-paced environment and gain consensus with groups.
Demonstrated ability to conduct quality investigations, including root cause analysis and determining corrective/preventive actions.
Collaborative and motivated team player, always looking to share and advance best practices.
Self-directed, pragmatic, and risk-based problem solver with strong analytical skills.
Experienced in data analysis tools (e.g., Minitab).
Experienced in electronic quality systems (CAPA, Change Control, Documentation Management).
Holds ASQ Certified Quality Engineer (CQE) and Lean Six Sigma Green/Black Belt certifications.

Responsibilities

Provide guidance and support for device manufacturing and quality control testing.
Evaluate deviations/out-of-specification conditions and data trending.
Lead quality investigations such as root cause analysis and corrective action plans.
Collaborate with cross-functional teams to support product and process changes.
Guide and support product validation and equipment qualifications.
Write or approve validation protocols and reports.
Create or revise Standard Operating Procedures (SOPs), Test Methods, and other quality-related documents.
Maintain compliance with ISO 9001 and QSR (cGMP) for medical devices.
Perform statistical analysis and trending to assess and monitor product or process performance.
Manage non-conforming product dispositions.
Conduct risk assessments (design and process FMEAs).
Support shelf-life studies.
Drive improvements in product quality, customer satisfaction, and operational efficiency.