Job Title: Supplier Quality Engineer / Principal Quality Engineer

Location: Newton, MA, 02466

Duration: 4+ Months

Job Type: Contract

Work Type: Onsite

Shift Timings: 1st Shift - 09:00am-5:00pm

Pay Rate: $70-$70/Hourly

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below client is with one of our client which is a leading global medical technology company. It offers a wide range of diagnostic imaging and laboratory diagnostics, as well as advanced therapies and digital health services. Its solutions span from prevention and early detection to diagnosis, treatment, and follow-up care, empowering healthcare providers worldwide.

Job Description:

• We are currently looking for an ambitious Principal Quality Engineer, Contractor to join our Endovascular Robotics business within Advanced Therapies.
• We are a global technology leader in robotic-assisted vascular interventions.
• We believe the combination of endovascular robotics, image guidance and dedicated devices will change the way neurovascular procedures will be done in the future, enabling better outcomes, and enabling our customers to provide better access to care.

Responsibilities:

• Represent the Quality Department as a subject matter expert in Incoming Inspection/Supplier Quality within a cross-functional team for new product development of medical devices.
• Develop and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of components/material/products and production equipment.
• Develop test plans, inspect, and assess material’s compliance based on dimensional and attribute acceptance criteria, while documenting and communicating inspection results.
• Determine optimal measurement devices to perform inspections. Understand AQL tables and how to select the correct sampling rate based on quality criteria.
• Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing
• Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.
• Lead the development and implementation of visual and physical inspections of injection molded, mechanical, electrical, and packaging components to ensure they meet specifications.
• Assist Quality Engineers and manufacturing personnel with calibration activities, which includes reviewing and retrieving calibrated equipment necessary for processing
• Managing Root Cause Analysis activities stemming from MRB, RMA, and CAPA.
• Analyzing/trending non-conformances through NCMRs and RMAs.
• Assist in supplier audits and visits, as required.
• Assist in the manufacturing transfer process including the creation and completion of planning documentation, DMR/DHR, and validation protocols (IQ, OQ, PQ).
• Support other duties as assigned by manager.

Required Knowledge/Skills, Education, and Experience

• Bachelor’s degree required in Engineering, Biomedical Engineering, or Life Sciences.
• Minimum of 10 years of experience as a Quality or Design Quality Engineer in the medical device industry supporting the development of complex electro-mechanical devices is required.
• Experience with new product development required.
• Working knowledge of QSR, MDD/MDR, ISO-13485 and ISO-14971 is required.
• Experience in metrology required.
• Strong organizational skills, detail oriented, and the ability to meet changing deadlines on a fast-moving environment.
• Strong documentation capability for protocol and report generation and review.
• Ability to communicate effectively within a technical environment.
• Team player who celebrates winning together
• No travel required.

Must-Have Skills:

• Experience with New Product Development.
• All required knowledge/skill on description. Here are some other experiences that are plus.
• Design Quality Engineering
• Validation Protocols
• FMEA Risk analysis
• Supplier qualifications
• Mechanical, Electric experience

TekWissen® Group is an equal opportunity employer supporting workforce diversity.