ATR International
We are seeking a Sr Quality Engineer for a very important client
A Day in the Life In this exciting role as a Senior Quality Engineer, you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initiatives. This is an onsite role at the Danvers, MA location. Responsibilities Include: • Provide Quality Engineering support for commercial medical device products. • Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product. • Collaborate with engineering and manufacturing functions to ensure quality standards are in place. • Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. • Design or specify inspection and testing mechanisms and equipment conducts quality assurance tests and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. • May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. • Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing. • Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements. • Present technical data to groups within and outside the organization. • 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.
Requirement:
Must Have: Minimum Qualifications • Bachelor's Degree in Engineering, Science or technical field AND 4 years of work experience in Engineering and/or Quality OR • Advanced Degree in Engineering, Science or technical field AND 2 years of work experience in Engineering and/or Quality.
Nice to Have: Preferred Qualifications oMedical Device oMaster's degree oManufacturing Experience oGreen Belt Six Sigma/DRM Training/Certification oASQ-CQE, CQA, CBA or equivalent certifications oSAP QM or SPC Software Experience oEffective verbal and written communication, analytical, influencing and interpersonal skills oWorking knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2016 oDemonstrated working knowledge of process validation, statistical methods, risk management
Top 3 technical skills that are required for the role: 1.Medical Device Design & Development 2.Risk Management: dFMEA, pFMEA, Statistical analysis 3.Technical Writing: IQs, PQs, TMVs
Education Required: • Bachelor's Degree in Engineering, Science or technical field AND 4 years of work experience in Engineering and/or Quality OR • Advanced Degree in Engineering, Science or technical field AND 2 years of work experience in Engineering and/or Quality
Years' Experience Required: 5 years
Nice To Have
• Green Belt Six Sigma/DRM Training/Certification • ASQ-CQE, CQA, CBA or equivalent certifications • SAP QM or SPC Software Experience • Effective verbal and written communication, analytical, influencing and interpersonal skills • Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2016 • Demonstrated working knowledge of process validation, statistical methods, risk management
Benefits:
Benefits Full-time employees (working an average of 30 hours or more) are eligible to select from different benefits packages Packages may include medical, dental, and vision benefits, a 401(k) retirement savings plan with employer match (available after 1 year of employment), commuter benefits, employee discount and referral programs, and life and supplemental income insurance Paid sick leave is provided in accordance with applicable state and local laws.
Compensation Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience, as well as the benefits package you select.
Work Authorization ATR International, Inc cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar) Candidates must have valid U.S work authorization.
ATR International, Inc is an equal opportunity employer We celebrate diversity and are committed to creating an inclusive environment for all employees.
A Day in the Life In this exciting role as a Senior Quality Engineer, you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initiatives. This is an onsite role at the Danvers, MA location. Responsibilities Include: • Provide Quality Engineering support for commercial medical device products. • Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product. • Collaborate with engineering and manufacturing functions to ensure quality standards are in place. • Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. • Design or specify inspection and testing mechanisms and equipment conducts quality assurance tests and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. • May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. • Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing. • Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements. • Present technical data to groups within and outside the organization. • 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.
Requirement:
Must Have: Minimum Qualifications • Bachelor's Degree in Engineering, Science or technical field AND 4 years of work experience in Engineering and/or Quality OR • Advanced Degree in Engineering, Science or technical field AND 2 years of work experience in Engineering and/or Quality.
Nice to Have: Preferred Qualifications oMedical Device oMaster's degree oManufacturing Experience oGreen Belt Six Sigma/DRM Training/Certification oASQ-CQE, CQA, CBA or equivalent certifications oSAP QM or SPC Software Experience oEffective verbal and written communication, analytical, influencing and interpersonal skills oWorking knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2016 oDemonstrated working knowledge of process validation, statistical methods, risk management
Top 3 technical skills that are required for the role: 1.Medical Device Design & Development 2.Risk Management: dFMEA, pFMEA, Statistical analysis 3.Technical Writing: IQs, PQs, TMVs
Education Required: • Bachelor's Degree in Engineering, Science or technical field AND 4 years of work experience in Engineering and/or Quality OR • Advanced Degree in Engineering, Science or technical field AND 2 years of work experience in Engineering and/or Quality
Years' Experience Required: 5 years
Nice To Have
• Green Belt Six Sigma/DRM Training/Certification • ASQ-CQE, CQA, CBA or equivalent certifications • SAP QM or SPC Software Experience • Effective verbal and written communication, analytical, influencing and interpersonal skills • Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2016 • Demonstrated working knowledge of process validation, statistical methods, risk management
Benefits:
Benefits Full-time employees (working an average of 30 hours or more) are eligible to select from different benefits packages Packages may include medical, dental, and vision benefits, a 401(k) retirement savings plan with employer match (available after 1 year of employment), commuter benefits, employee discount and referral programs, and life and supplemental income insurance Paid sick leave is provided in accordance with applicable state and local laws.
Compensation Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience, as well as the benefits package you select.
Work Authorization ATR International, Inc cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar) Candidates must have valid U.S work authorization.
ATR International, Inc is an equal opportunity employer We celebrate diversity and are committed to creating an inclusive environment for all employees.