Quality Engineer

Danvers, IL - USA

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

Position: Sr Quality Engineer
Location: Danvers MA (100% on-site)
Duration of project: 12 months

Requirements:

Medical Device Design & Development
Risk Management: dFMEA pFMEA Statistical analysis
Technical Writing: IQs PQs TMVs
Hands on experience on upstream new product development vs downstream manufacturing transfer and operations quality
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
Green Belt Six Sigma/DRM Training/Certification is preferred but not required
ASQ-CQE CQA CBA or equivalent certifications preferred but not required
SAP QM or SPC Software experience preferred but not required

Education Required:

Bachelors Degree in Engineering Science or technical field AND 5-7 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
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.

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.
Able to present quality during new product introduction projects and provide quality support for documentation changes change control process transfer and equipment installation
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.

Position: Sr Quality Engineer Location: Danvers MA (100% on-site) Duration of project: 12 months Requirements: Medical Device Design & Development Risk Management: dFMEA pFMEA Statistical analysis Technical Writing: IQs PQs TMVs Hands on experience on upstream new product development vs dow...

Position: Sr Quality Engineer
Location: Danvers MA (100% on-site)
Duration of project: 12 months

Requirements:

Medical Device Design & Development
Risk Management: dFMEA pFMEA Statistical analysis
Technical Writing: IQs PQs TMVs
Hands on experience on upstream new product development vs downstream manufacturing transfer and operations quality
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
Green Belt Six Sigma/DRM Training/Certification is preferred but not required
ASQ-CQE CQA CBA or equivalent certifications preferred but not required
SAP QM or SPC Software experience preferred but not required

Education Required:

Bachelors Degree in Engineering Science or technical field AND 5-7 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
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.

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.
Able to present quality during new product introduction projects and provide quality support for documentation changes change control process transfer and equipment installation
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.