Current jobs related to Quality Engineer - Bedford - Lexington Medical, Inc.
-
Quality Engineer
1 month ago
Bedford, United States Lexington Medical, Inc. Full timeLexington Medical is a medical device manufacturer in the greater Boston area that produces minimally invasive surgical stapling solutions. Our unique customer-centric approach to engineering has allowed us to be agile and responsive to the stapling market. Our business structure enables us to produce a unique range of devices and proprietary technology best...
-
Quality Engineer
1 month ago
Bedford, United States Lexington Medical, Inc. Full timeLexington Medical is a medical device manufacturer in the greater Boston area that produces minimally invasive surgical stapling solutions. Our unique customer-centric approach to engineering has allowed us to be agile and responsive to the stapling market. Our business structure enables us to produce a unique range of devices and proprietary technology best...
-
Quality Engineer
3 weeks ago
Bedford, United States Actalent Full timeA great opportunity to work with a growing Robotics company! Job Description •Lead the development and execution of comprehensive hardware quality assurance plans. •Design, implement, and oversee testing protocols for hardware components and systems. •Conduct root cause analysis and drive corrective actions to address quality issues. •Collaborate...
-
Quality Engineer
4 weeks ago
Bedford, United States Actalent Full timeA great opportunity to work with a growing Robotics company! Job Description Lead the development and execution of comprehensive hardware quality assurance plans. Design, implement, and oversee testing protocols for hardware components and systems. Conduct root cause analysis and drive corrective actions to address quality issues. Collaborate with...
-
Senior Quality Engineer
2 months ago
Bedford, United States InfraredX, Inc. Full timeJob DescriptionJob DescriptionSenior Quality EngineerProvide engineering support to ensure the quality of design, sourcing and manufacturing of products at Infraredx. Provide input to the development teams in the manufacturing transfer of complex electromechanical medical devices. Develop, review, and implement engineering changes. Support establishment of...
-
Senior Quality Engineer
2 months ago
Bedford, United States Infraredx, a Nipro Company Full timeProvide engineering support to ensure the quality of design, sourcing and manufacturing of products at Infraredx. Provide input to the development teams in the manufacturing transfer of complex electromechanical medical devices. Develop, review, and implement engineering changes. Support establishment of quality inspection criteria. Develop, establish and...
-
Senior Quality Engineer
2 months ago
Bedford, United States Infraredx, a Nipro Company Full timeProvide engineering support to ensure the quality of design, sourcing and manufacturing of products at Infraredx. Provide input to the development teams in the manufacturing transfer of complex electromechanical medical devices. Develop, review, and implement engineering changes. Support establishment of quality inspection criteria. Develop, establish and...
-
Quality Engineer
6 days ago
Bedford Park, United States Manpower Engineering Full timeOur client, an aerospace manufacturing company, is seeking a Quality Engineer to join their team. As a Quality Engineer, you will be part of the Quality Team supporting NPI, Suppliers, and Operations support. This person would need to be onsite in Bedford Park, IL 60638. Job Title: Quality Engineer Location: Bedford Park, IL 60638 Pay Range:...
-
Hardware Quality Engineer
3 weeks ago
Bedford, Massachusetts, United States Actalent Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Actalent. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and reliability of our products.Key ResponsibilitiesDevelop and execute comprehensive quality assurance plans to ensure the quality and reliability of our...
-
Quality Engineer
6 days ago
Bedford Park, United States Manpower Engineering Full timeOur client, an aerospace manufacturing company, is seeking a Quality Engineer to join their team. As a Quality Engineer, you will be part of the Quality Team supporting NPI, Suppliers, and Operations support. This person would need to be onsite in Bedford Park, IL 60638. Job Title: Quality Engineer Location: Bedford Park, IL 60638 Pay Range:...
-
Quality Engineer Co-Op
4 weeks ago
Bedford, United States Entegris Full timeJob Title: Quality Engineer Co-Op Job Description: Quality Engineer Co-Op - Spring 2025 Here at Entegris, we use advanced science to enable technologies that transform the world, and we are seeking employees who have the drive to continue the mission. The Role: Our site in Bedford is seeking a/an Quality Engineer Co-Op to join our team for the Spring 2025...
-
Senior Quality Engineer
4 months ago
Bedford, United States Entegris Full timeCompany Overview and Values: Why work at Entegris? Lead. Inspire. Innovate. Define Your Future. Not everyone who works for a global company shares the same background, experiences and perspectives. We leverage the differences of our employees to bring new ideas to the table. Every employee throughout the company is encouraged to share input on projects and...
-
Quality System Engineer
3 weeks ago
Bedford, United States InfraReDx Full timeResponsibilities• Supports the complaint handling process for the organization. Responsible for activities required to ensure compliance of Infraredx Quality Management Systems (QMS), specifically regarding Customer Complaints. Additional responsibilities include supporting other QMS functions such as Management Review, CAPAs, NMRs, Risk Review, etc. •...
-
Quality System Engineer
2 months ago
Bedford, United States InfraReDx Full timeResponsibilities• Supports the complaint handling process for the organization. Responsible for activities required to ensure compliance of Infraredx Quality Management Systems (QMS), specifically regarding Customer Complaints. Additional responsibilities include supporting other QMS functions such as Management Review, CAPAs, NMRs, Risk Review, etc. •...
-
Quality Engineer Co-Op
3 weeks ago
Bedford, United States Entegris Full timeJob Title:Quality Engineer Co-OpJob Description:Quality Engineer Co-Op - Spring 2025Here at Entegris, we use advanced science to enable technologies that transform the world, and we are seeking employees who have the drive to continue the mission.The Role:Our site in Bedford is seeking a/an Quality Engineer Co-Op to join our team for the Spring 2025 season....
-
Lead Quality Assurance Engineer
4 weeks ago
Bedford, Massachusetts, United States InfraredX, Inc. Full timeLead Quality Assurance EngineerAs a Lead Quality Assurance Engineer at InfraredX, you will play a crucial role in ensuring the excellence of our product designs, sourcing, and manufacturing processes. Your expertise will guide the development teams during the transition of intricate electromechanical medical devices from concept to production. You will be...
-
Principal Supplier Quality Engineer
4 months ago
Bedford, United States InfraredX, Inc. Full timeJob DescriptionJob DescriptionResponsible for ensuring that Infraredx’s suppliers provide high quality materials and/or services that conform to the needs of Infraredx product quality and regulatory requirements. Key team member providing expertise on the capability of our suppliers, in establishing and maintaining the technical activities of our...
-
Principal Supplier Quality Engineer
4 months ago
Bedford, United States Infraredx, a Nipro Company Full timeResponsible for ensuring that Infraredx’s suppliers provide high quality materials and/or services that conform to the needs of Infraredx product quality and regulatory requirements. Key team member providing expertise on the capability of our suppliers, in establishing and maintaining the technical activities of our suppliers, and ensuring they meet...
-
Quality Engineer II
2 months ago
Bedford, United States Anika Full timeSummary of Primary Responsibilities:This position is responsible for providing support for manufacturing support for commercial products through review and approval of Process Change Controls, CAPAs and Deviations. Support new product development as needed. Performs Internal audits as assigned. Participates in customer and regulatory audits as part of the...
-
Quality Engineer II
2 months ago
Bedford, United States Anika Full timeSummary of Primary Responsibilities:This position is responsible for providing support for manufacturing support for commercial products through review and approval of Process Change Controls, CAPAs and Deviations. Support new product development as needed. Performs Internal audits as assigned. Participates in customer and regulatory audits as part of the...
Quality Engineer
3 months ago
Our recruiting philosophy is centered on attracting talented individuals committed to delivering innovation. Rooted in a talent dense culture that fosters continuous growth and achievement, both personal and organizationally, we've been organically scaling at a rapid pace and have aggressive hiring plans for the years ahead. By joining Lexington Medical, you will have the opportunity to impact the lives of millions of patients worldwide and thrive in a growing company.
As a Quality Engineer at Lexington Medical, you will drive the quality system and design assurance activities and play a key role in creating a world-class quality management system and building a quality function that is core to the company's success.
What you will do:
- 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
- Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related field
- 2+ 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
- Supplier quality experience is a plus
- Strong team orientation and ability to lead in a cross-functional environment