Quality Engineer II
Teleflex
full-time
Posted on:
Location Type: Office
Location: Chelmsford • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $82,600 - $123,900 per year
Job Level
Junior
About the role
- Independently review and approve quality records, change controls, and production documentation to ensure compliance with internal procedures and regulatory standards.
- Lead the execution of validation activities (IQ/OQ/PQ), test method validation (TMV), and Gage R&R studies by ensuring adherence to protocols and proper data collection.
- Use statistical tools (e.g., control charts, capability analysis, t-tests) to analyze process data and support decision-making related to process capability and improvement.
- Lead risk assessments and drive PFMEA development or updates in coordination with engineering, manufacturing, and regulatory teams.
- Own nonconformance investigations, perform root cause analysis, and support timely and effective CAPA development and closure.
- Author or revise inspection plans, manufacturing procedures, and test methods to ensure appropriate inspection coverage and risk mitigation.
- Support and represent the quality function during internal audits and regulatory inspections by demonstrating compliance with documented processes.
- Independently execute sampling plans and conduct measurement system evaluations to ensure data reliability and inspection readiness.
- Review and assess supplier quality documentation; participate in supplier evaluations and support resolution of incoming material issues.
- Lead or contribute significantly to structured problem-solving and continuous improvement initiatives within the quality or operations function.
- Provide quality guidance for assigned product lines or processes, including support during engineering changes, deviation management, or issue resolution.
- Review and assess quality impact of process or equipment changes and contribute to technical justifications and change control documentation.
- Communicate quality risks, investigation results, and quality metrics effectively to team leaders, cross-functional stakeholders, and management.
Requirements
- Bachelor’s degree in engineering, science, or related field.
- 1–3 years of experience in quality or manufacturing engineering in a regulated environment.
- Working knowledge of ISO 13485, 21 CFR 820, and internal QMS standards.
- Proficiency in core quality tools (FMEA, Gage R&R, basic DOE).
- Basic understanding of manufacturing controls and process validation.
- Ability to execute tasks independently and participate in cross-functional initiatives.
- Proficient in Microsoft Office; experience with statistical tools preferred.
- Familiar with continuous improvement principles (Lean, Six Sigma).
- Strong organizational skills and attention to detail.
Benefits
- medical, prescription drug, dental and vision insurance
- flexible spending accounts
- participation in 401(k) savings plan
- various paid time off benefits, such as PTO, short- and long-term disability and parental leave
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality records reviewchange controlsproduction documentationvalidation activitiestest method validationstatistical toolsroot cause analysisCAPA developmentsampling plansprocess validation
Soft skills
organizational skillsattention to detailindependent executioncross-functional collaborationcommunication skills
Certifications
Bachelor’s degree in engineeringBachelor’s degree in science