- Utilize risk-based approach in the classification and management of Infraredx suppliers.
- Manage supplier issues arising at incoming inspection or on manufacturing floor.
- Resolution of quality issues including supplier non-conformances, corrective action requests, and CAPA.
- Lead the qualification of new suppliers, including supplier selection and approval.
- Responsible for coordinating initial component quality requirements, including first article inspection, process qualification, and assisting in supplier validation activities such as writing/approving protocols.
- Provide insight regarding supplier capabilities for new and existing products, in collaboration with manufacturing, engineering, R&D, and marketing.
- Conduct external supplier audits to ensure compliance. Independently manage resolution of quality issues observed during audit process to raise level of supplier performance to Infraredx standards.
- Execute and enforce Supplier and/or Distributor Quality Agreements.
- Maintain supplier quality records in accordance with FDA/GMP and EU MDR requirements.
- Lead the review of supplier change requests with cross-functional team, including evaluation of change, implementation planning, and approval.
- Generate KPI's and supplier metrics, including producing quarterly scorecards for supply base as defined.
- Ability to identify under-performing suppliers and work with them to improve or reduce defect occurrence rates, initiating transfer activities to alternative suppliers if 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.
- Ability to work independently, managing all requirements of supplier management program. Where possible, propose and implement continuous improvements for responsible areas.
- Mentor and develop quality personnel and/or organizational partners.
- Support contract manufacturers on quality issues resolution and change requests.
- Bachelor of Science degree in a technical discipline. Engineering discipline required.
- 10+ years of quality engineering in life sciences industry, 5+ years supplier quality experience required.
- Self-sufficient. Able to research and understand foreign manufacturing processes and provide input on process improvements and/or defect resolution. Role may require periodic meetings during off-hours to support or address issues arising at foreign manufacturers.
- Proven track record with supplier selection, approval, and management.
- Prior management or supervisory experience preferred.
- 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
1 week ago
SUMERU INC Westborough, United States**Key Responsibilities**: · - Works with R&D, Manufacturing Engineers, Product Managers and Supplier Quality to ensure robust triage of product complaints and associated investigations; responsible for documentation of objective evidence in QMS records. · - Writes and reviews tec ...
-
Quality Engineer
2 days ago
Spectrum Industries Cambridge, United StatesDigital transformation. Sustainability. Peacekeeping. Exciting tasks that we at Diehl, in our five subgroups Metall, Controls, Defence, Aviation, and Metering, and our over employees are working on with high pressure. Discover fascinating technologies and apply now. In a family-o ...
-
Quality Engineer
2 days ago
Velocity Solutions North Walpole, United StatesAbout the Company · As a system partner of the office furniture industry, we specialize in the development and production of functional fittings made of metal and plastic. As one of the leading companies in Europe, we strive to quickly and flexibly fulfill individual customer req ...
-
Quality Engineering Technician
2 days ago
Pursuit Aerospace Malden, United States**Quality Engineering Technician** · Malden, MA, US · **About Pursuit Aerospace** · Pursuit Aerospace is the largest privately held aerospace manufacturers in the world. We are a global manufacturer of complex aircraft engine components that are developed through highly integrate ...
-
Senior Quality Engineer
2 weeks ago
SpectraWAVE, Inc. Bedford, United StatesThe Company · SpectraWAVE is a commercial stage fast-paced medical device start-up, with a mission to provide unrivaled optical and computational insights to improve treatment and outcomes for patients with coronary artery disease – the number one cause of mortality in the world ...
-
Senior Quality Engineer
3 weeks ago
Berkshire Grey Bedford, United StatesA Senior Quality Engineer is expected to: · Serve as the customer quality advocate on assigned program team. · Ensure that critical product characteristics (form, fit, function, safety) are identified on engineering specifications for design qualification and process control. ...
-
Senior Quality Engineer
3 weeks ago
Berkshire Grey Bedford, United StatesA Senior Quality Engineer is expected to: · Serve as the customer quality advocate on assigned program team. · Ensure that critical product characteristics (form, fit, function, safety) are identified on engineering specifications for design qualification and process control. ...
-
Senior Quality Engineer
3 weeks ago
SpectraWAVE, Inc. Bedford, United StatesThe Company · SpectraWAVE is a commercial stage fast-paced medical device start-up, with a mission to provide unrivaled optical and computational insights to improve treatment and outcomes for patients with coronary artery disease the number one cause of mortality in the world.S ...
-
Senior Quality Engineer
1 week ago
SpectraWAVE, Inc. Bedford, United StatesThe Company · SpectraWAVE is a commercial stage fast-paced medical device start-up, with a mission to provide unrivaled optical and computational insights to improve treatment and outcomes for patients with coronary artery disease - the number one cause of mortality in the world. ...
-
Senior Quality Engineer
3 weeks ago
Entegris Bedford, United StatesCompany 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 ta ...
-
Quality Engineer
3 weeks ago
Astrix Technology Burlington, United StatesQuality Engineer · Quality Assurance · Burlington, MA, US · Pay Rate Low: 35 | Pay Rate High: 44 · + Added - 01/04/2024 · Apply for Job · **Job Description:** · + Support manufacturing processes for medical implant and medical external cable assemblies, with a primary focu ...
-
Quality Engineer
3 weeks ago
Precision Life Sciences Burlington, United StatesJob Description: Quality Engineer · The Quality Engineer will support sustaining engineering and new product development activity for the Quality Assurance department in a dynamic and complex engineering environment. · RESPONSIBILITIES · Support sustaining engineering through ope ...
-
Quality Engineer
1 week ago
Precision Life Sciences Burlington, United StatesJob Description: Quality Engineer · The Quality Engineer will support sustaining engineering and new product development activity for the Quality Assurance department in a dynamic and complex engineering environment. · RESPONSIBILITIES · Support sustaining engineering through ...
-
Quality Engineer
1 week ago
INTELLECTT INC Burlington, United StatesRole: Engineer · Location: Burlington, MA · Duration: 6 Months · Shift Timings: 8 AM to 5 PM · Main Purpose Of Role · Perform failure analysis on explanted biomedical implant product. Provide technical expertise to the product Analysis Laboratory. Analyzes failures, develops ...
-
Quality Engineer
1 week ago
Katalyst HealthCares & Life Sciences Burlington, United StatesResponsibilities: Perform failure analysis on explanted long-term biomedical implant product. · Work requires the application of theoretical principals, evaluation, ingenuity, and creative/analytical. · Must be able to meet deadlines on multiple assignments and be able to oper ...
-
Quality Engineer Intern
2 weeks ago
Novanta Bedford, United StatesBuild a career powered by innovations that matter At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing-improving productivity, enhancing people's lives and redefining what's possible. We create for our global customers ...
-
Quality Engineer Intern
1 week ago
Novanta Bedford, United StatesThank you for your interest in Novanta. You have taken the first step towards a new career opportunity. We invite you to complete your application. By taking this step, your information will be stored for future submissions to our open jobs according to Novanta's · Data Privacy ...
-
Quality Engineer
2 weeks ago
Randstad USA Billerica, United StatesJob Summary · Our client north of Boston is looking for a Quality Engineer to join their growing team This is a great opportunity for someone who is looking for a team oriented environment. Our client is very focused on working together to complete projects using cross collaborat ...
-
Quality Engineer Intern
3 weeks ago
Novanta Bedford, United StatesBuild a career powered by innovations that matter At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing-improving productivity, enhancing people's lives and redefining what's possible. We create for our global customers ...
-
Quality Engineer
2 weeks ago
Randstad Billerica, United StatesJob Summary · Our client north of Boston is looking for a Quality Engineer to join their growing team This is a great opportunity for someone who is looking for a team oriented environment. Our client is very focused on working together to complete projects using cross collabora ...
Principal Supplier Quality Engineer - Bedford, United States - Infraredx, a Nipro Company
2 weeks ago
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:
