Teleflex · 3 days ago
Quality Engineer II
Chelmsford, MA
Full-time
Onsite
Entry, Mid Level
$83K/yr - $124K/yr
1+ years expTeleflex is a global provider of medical technologies focused on improving health and quality of life. The Quality Engineer II will independently execute quality engineering activities to support compliant manufacturing processes and collaborate with cross-functional teams to enhance product and process quality throughout the product lifecycle.
CommercialHealth CareMedicalMedical Device
Hiring Manager
Lexy (Mayer) Cianfrani
Responsibilities
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
Qualification
Required
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
Strong organizational skills and attention to detail
Preferred
Experience with statistical tools preferred
Familiar with continuous improvement principles (Lean, Six Sigma)
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
Company
Teleflex
Teleflex is a manufacturing company that designs and develops medical devices for the healthcare sector.
10001+ employees
H1B Sponsorship
Teleflex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (2)
2023 (3)
2022 (2)
2021 (4)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$400M2016-05-12Post Ipo Debt· $400M
1990-01-01IPO
Leadership Team
Liam Kelly
Chairman, President and CEO
Cameron Hicks
Corporate Vice President and Chief Human Resources Officer
Recent News
GlobeNewswire
2026-01-09
2026-01-09
2026-01-09
Company data provided by crunchbase