42 applicants

Company

Original Job Post

Lexington Medical, Inc · 4 days ago

Senior Quality Engineer

Bedford, MA

Full-time

Onsite

Senior Level

5+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

Health CareManufacturing

H1B Sponsorship

Insider Connection @Lexington Medical, Inc

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Drive Design Assurance activities throughout the Product Life Cycle

Provide expertise in Risk Management, Design Verification and Validation, Statistical Methods and Design Controls

Define and implement processes within the Quality Management System

Drive quality system execution to US and international standards, including development of quality and risk management plans

Drive continuous improvement projects, and proactively identify and implement best-in-class quality engineering practices

Develop test methods and inspection procedures and implement process control systems to support the development, qualification, and on-going manufacturing of products

Support supplier quality management, including conducting sub-contractors and component supplier audits

Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues

Provide guidance to junior members of the team

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Design Quality EngineeringQuality Management SystemsNew Product DevelopmentDesign TransferUS Medical Device RegulationsInternational Medical Device StandardsDesign ControlsProcess ValidationRisk ManagementChange ControlMaterial Review BoardsProblem-SolvingTeam OrientationLeadershipSupplier Quality

Required

Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related field

5+ years of experience in design quality engineering, in the medical device industry (experience with electrical equipment is a plus)

Experience developing and implementing processes within quality management systems.

Experience in new product development and introduction (NPD/NPI), and in design transfer

Strong working knowledge of US and international medical device regulations and standards, including 21 CFR 820, EU 2017/45 (MRD), ISO 13485, ISO 14971, IEC 60601, and IEC 62366

Demonstrated knowledge of design controls, process validation, risk management, and change control

Demonstrated application of systematic problem-solving techniques and defect avoidance methodologies

Experience participating in material review boards

Strong team orientation and ability to lead in a cross-functional environment

Preferred

Supplier quality experience is a plus

Company

Lexington Medical, Inc

Lexington Medical is singularly focused on making the best surgical stapler in the world.

Founded in 2015

Billerica, Massachusetts, USA

51-200 employees

https://www.lexington-med.com/

H1B Sponsorship

Lexington Medical, Inc 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

Trends of Total Sponsorships

2023 (1)

2022 (1)

2021 (1)

2020 (1)