Michael Page
Pr Quality Engineer- NPI Medical- Wellesley, MA
Michael Page, Wellesley, Massachusetts, us, 02482
The Principal Quality Engineer will drive and support all aspects of the quality system, ensuring quality in new product introductions and manufacturing. This role reports to the Senior Director of Quality.
Applying for this role is straight forward Scroll down and click on Apply to be considered for this position.Client DetailsThis biotechnology company focuses on creating sustainable chemicals and materials from natural silk protein. Their innovations enhance the health and sustainability of products across industries such as personal care, textiles, and medical devices.DescriptionLead risk analysis, FMEAs, and support verification/validation in the product development process, ensuring quality in manufacturing transfers.Participate in design reviews and transfers, guiding Design and Change Control processes.Ensure compliance with the Quality Policy and FDA Quality System Requirements in all work activities.Review and approve batch records, DHRs, and batch releases promptly.Lead the MRB team for timely disposition of deviations and nonconforming materials.Manage CAPAs, complaint investigations, and lifecycle deviations, identifying trends for corrective actions.Mentor quality team members and provide best practice guidance.Support regulatory compliance activities and certification/recertification for various markets.Serve as an Internal Auditor and develop effective quality plans.ProfileBachelor's degree and 10+ years in Quality Engineering with combination or single-use devices, or Master's degree and 8+ years.Degree in Chemical, Industrial, Process, Biomedical Engineering, or a related science.Proven use of quality tools and techniques in manufacturing.
Skills & Abilities:
Detail-oriented.Strong written and verbal communication.Excellent problem-solving skills.Proficient in ISO 13485 and FDA QSR standards.Internal or lead auditor experience is a plus.Experience with MasterControl is a plus
Job Offerroom for growth and ability to make an impact at a great company as they scale.MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
Applying for this role is straight forward Scroll down and click on Apply to be considered for this position.Client DetailsThis biotechnology company focuses on creating sustainable chemicals and materials from natural silk protein. Their innovations enhance the health and sustainability of products across industries such as personal care, textiles, and medical devices.DescriptionLead risk analysis, FMEAs, and support verification/validation in the product development process, ensuring quality in manufacturing transfers.Participate in design reviews and transfers, guiding Design and Change Control processes.Ensure compliance with the Quality Policy and FDA Quality System Requirements in all work activities.Review and approve batch records, DHRs, and batch releases promptly.Lead the MRB team for timely disposition of deviations and nonconforming materials.Manage CAPAs, complaint investigations, and lifecycle deviations, identifying trends for corrective actions.Mentor quality team members and provide best practice guidance.Support regulatory compliance activities and certification/recertification for various markets.Serve as an Internal Auditor and develop effective quality plans.ProfileBachelor's degree and 10+ years in Quality Engineering with combination or single-use devices, or Master's degree and 8+ years.Degree in Chemical, Industrial, Process, Biomedical Engineering, or a related science.Proven use of quality tools and techniques in manufacturing.
Skills & Abilities:
Detail-oriented.Strong written and verbal communication.Excellent problem-solving skills.Proficient in ISO 13485 and FDA QSR standards.Internal or lead auditor experience is a plus.Experience with MasterControl is a plus
Job Offerroom for growth and ability to make an impact at a great company as they scale.MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.