- Utilize risk-based approach in the classification and management of Infraredx suppliers.
- Provide daily support for supplier issues arising at incoming inspection or on manufacturing floor.
- Interface with suppliers to obtain quality data and resolve quality issues. Resolution of quality issues to include responsibility of supplier non-conformances, corrective action requests, and CAPA.
- Participate in qualification of new suppliers, including supplier selection and approval.
- Responsible for coordination of initial component quality requirements including first article inspection, process qualification, and assisting in supplier validation activities such as writing/approving protocols.
- Responsible for maintaining the Approved Supplier List.
- Provide insight regarding supplier capabilities for new and existing products, in collaboration with manufacturing, engineering, R&D, and marketing.
- Conducts external supplier audits, as assigned, to ensure QMS compliance.
- Maintains supplier quality records in accordance with FDA/GMP and EU MDR requirements.
- Coordinate review of supplier change requests with cross-functional team, including evaluation of change, implementation planning, and approval.
- Assist with supplier quarterly evaluation activities (Supplier Performance Scorecard).
- Ability to identify under-performing suppliers and work to improve them or reduce defect occurrence rates, initiating transfer activities to alternative suppliers when necessary.
- Consolidation of supply base through identification of redundant capabilities and initiating/supporting manufacturing or service transfers as needed.
- Initiate and drive process/yield improvement projects where possible.
- Develop and support requirements and activities for "dock-to-stock" program.
- Acts as a team member in supporting quality disciplines, decisions, and practices.
- Bachelor of Science degree in a technical discipline.
- 5-7+ years of quality engineering in life sciences industry, supplier quality experience strongly preferred.
- Proven track record with supplier selection, approval, and management.
- Strong written/verbal communication skills and demonstrated use of quality tools/methodologies.
- Working knowledge of FDA/QSR, ISO, EU MDR standards, process validation, product design control, CAPA, and FMEA methodologies.
- Proficient with Microsoft Office applications, and willingness to learn Infraredx ERP and PLM systems.
- Certified Internal Auditor and/or experience performing Internal Audits strongly preferred.
- Current ASQ and/or six sigma certifications preferred.
-
Quality Engineer
3 days ago
Optics 1 Inc. Bedford, United StatesABOUT OUR MISSION: · Optics 1, Inc., a Safran Group Company, is a technology leader in the design, development, and production of Integrated Electro-optical Systems for commercial and government applications. Leveraging our multi-disciplined engineering expertise in optics, elect ...
-
Quality Engineer
3 weeks ago
Knowles Precision Devices New Bedford, United StatesJob Description · Job DescriptionDescriptionThe Quality Assurance Engineer is responsible for product and process quality through implementing and maintaining Quality Assurance Programs & Plans, an ISO 9001 Quality Management System, and leading/facilitating data driven process i ...
-
Quality Engineer
4 weeks ago
Knowles Precision Devices New Bedford, United StatesQuality Engineer · Department: Manufacturing · Employment Type: Full Time · Location: New Bedford, Massachusetts · Reporting To: Quality Manager · Compensation: $75,000 - $85,000 / year · Description · The Quality Assurance Engineer is responsible for product and process qu ...
-
Quality Engineer
3 weeks ago
Knowles Corporation New Bedford, United StatesQuality Engineer · Department: · Manufacturing · Employment Type: · Full Time · Location: · New Bedford, Massachusetts · Reporting To: · Quality Manager · Compensation: · $75,000 - $85,000 / year · Description · The Quality Assurance Engineer is responsible for product an ...
-
Supplier Quality Engineer
2 weeks ago
Morgan Advanced Materials New Bedford, United StatesOverview · Morgan Advanced Materials · is a business rich in history and innovation. Founded in the UK in 1856, we have grown into a global organisation with 70 sites in 18 countries. Our model to serve our customers where they need us has led to a diversified product range usi ...
-
Quality Engineer
2 weeks ago
Jobot Bristol, United StatesJob Description · Job DescriptionGenerous PTO, vacation, sick, and holidays · This Jobot Job is hosted by: Nick Strebig · Are you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume. · Salary: $80,000 - $105,000 per year · A bit about us: · As a pro ...
-
Senior Supplier Quality Engineer Job
4 weeks ago
InfraredX, Inc. Bedford, MA, United States 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. Utilize risk-based approach in the classification and management of Infraredx suppliers. · Provi ...
-
Quality Engineer
6 hours ago
Jobot Providence, United StatesJob Description · Job DescriptionThis Jobot Job is hosted by: Casey Caldwell · Are you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume. · Salary: $70,000 - $100,000 per year · A bit about us: · Growing Medical Device Manufacturing Company · Why ...
-
Quality Engineer
1 day ago
Actalent Raynham, United States: The Laboratory Quality Engineer is responsible for the completion of quality deliverables within the laboratory including Audit, CAPA, and Nonconformance investigation and management to meet quality performance measures established by the business. This role is responsible for ...
-
quality engineer
3 weeks ago
SINCLAIR MANUFACTURING COMPANY LLC Norton, United StatesJob Description · Job DescriptionDescription:Responsible for providing support for the following Quality tasks and duties: introduction and launching of new or improved products and processes into the plant. Lead problem-solving teams. Facilitate from a Quality & Quality Engineer ...
-
Quality Engineer
5 days ago
Insight Global Raynham, United StatesThe Quality Engineer will be participating in manufacturing readiness activities. This is not NPI/full scale process validation, but we are introducing systematically new codes. There will be some business and quality systems work. The primary objective will be a gap assessment a ...
-
Quality Engineer
5 days ago
Cynet Systems Raynham, United StatesJob Description: · Responsibilities: · Business Improvements: Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements. · Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques, and/or ...
-
Quality Engineer
1 week ago
American Honda Motor Greensburg, United StatesWhat Makes a Honda, is Who makes a Honda · Honda has a clear vision for the future, and its a joyful one. We are looking for individuals with the skills, courage, persistence, and dreams that will help us reach our future-focused goals. · At our core is innovation. Honda is con ...
-
Manufacturing Quality Engineer
1 day ago
DSJ Global Massachusetts, United StatesDSJ Global is partnered with a leading company in the High-Performance Power Modules industry. This company designs and manufactures power converters, power supplies, and other power management solutions. They are looking to add a Manufacturing Quality Engineer with a focus in Yi ...
-
Quality Assurance Engineer
1 day ago
CPS Technologies Corp. Norton, United StatesBASIC FUNCTION: · Function as a lead member of the CPS Quality Assurance Team in supporting CPS Operations to ensure that our products always meet the requirements of our customers · MINIMUM REQUIREMENTS: · Understanding of ISO 9001 Quality Management System requirements · Compet ...
-
Design Quality Engineer
5 days ago
IntePros Raynham, United StatesDesign Quality Engineer: · We are seeking a Design Quality Engineer to join our team. The ideal candidate will have a deep understanding of design quality, process verification, gap assessment, supplier quality, and new product development. You will be responsible for reviewing d ...
-
Spectrum Dynamics Bedford, United StatesAre you passionate about making a real impact with your job? Find your place in one of over 500 professions at Deutsche Bahn. We offer professionals and career starters secure jobs with future prospects. Apply now to join a team that supports each other and looks forward to worki ...
-
Weld Quality Engineer
1 week ago
American Honda Motor Greensburg, United StatesWhat Makes a Honda, is Who makes a Honda · Honda has a clear vision for the future, and its a joyful one. We are looking for individuals with the skills, courage, persistence, and dreams that will help us reach our future-focused goals. · At our core is innovation. Honda is con ...
-
Quality Assurance Engineer
1 week ago
The Staffing Resource Group Inc Swedesboro, United StatesQuality Assurance Engineer Salary: Up to$55/hrLocation: Swedesboro, NJ (hybrid less than 50%)Industry: Government/DefenseEmployment Type: Long-term contract with potential for permanent employmentQualifications: BS Degree in related field 2+ years of relevant QA Engineering exper ...
-
Customer Quality Engineer
5 days ago
Bühler Inc Plymouth, United StatesAre you passionate about delivering exceptional customer service and driving quality improvements? Join Buhler as a Customer Quality Engineer, where your primary role will be to advocate for our customers and ensuring their issues are resolved with expedience and precision. In th ...
Senior Supplier Quality Engineer - Bedford, United States - Infraredx
Description
Responsible 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 business needs.Key Responsibilities:
Requirements:
