Save Job Back to Search Job Description Summary Similar JobsLead quality strategy for innovative Class III medical technologiesOwn design controls and risk management in a growing organisationAbout Our ClientOur client is an innovative medical technology company focused on developing life-changing therapies that improve patient outcomes worldwide. They combine cutting-edge engineering with a strong quality culture, offering employees the opportunity to make a meaningful impact while working alongside highly experienced industry leaders.Job DescriptionAct as the Design Controls subject matter expert, ensuring compliance throughout all phases of product development.Partner closely with Product Development teams to drive quality activities for new product introductions and design changes.Lead risk management activities, including risk assessments, risk management plans, and risk management reports.Own and maintain risk documentation supporting product and process development activities.Manage Design History File reviews and verification's throughout the design life cycle.Review and approve engineering change documentation while assessing associated product risks.Support the development, revision, and continuous improvement of quality system procedures and documentation.Review validation protocols and reports to ensure compliance with regulatory and GMP requirements.Conduct internal audits and support Quality Management System effectiveness.Lead investigations related to nonconformances, customer complaints, and corrective actions.Drive timely resolution of quality issues through root cause analysis and corrective action implementation.Provide quality system training and mentorship across the organization.Support compliance with ISO 13485, FDA regulations, MDSAP, MDR, and other global quality standards.Develop technical procedures, failure analysis documentation, and quality engineering reports.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.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.The Successful ApplicantBachelor's degree in Electrical Engineering; advanced degree preferred.10+ years of experience within medical devices or another highly regulated industry.Strong experience in Design Controls and Product Development support.Expertise with Risk Management methodologies, including authoring and facilitating risk assessments.Thorough understanding of ISO 13485, FDA 21 CFR Part 820, MDSAP, MDR, and related regulations.Experience supporting Design History Files, validation activities, and quality system compliance.Ability to work independently while effectively collaborating across cross-functional teams.Excellent technical writing, communication, project management, and problem-solving skills.Background in medical instrumentation preferred.Experience within medical devices, defense, military, or similarly regulated industries highly valued.What's on OfferDirect impact on breakthrough medical technologies that improve patient's lives.Highly visible role partnering with engineering and executive leadership.Opportunity to lead quality strategy across the entire product development life cycle.Exposure to advanced medical device technologies in a complex regulatory environment.Strong career growth potential within an innovative and expanding organization.ContactTaylor RankinQuote job refJN-062026-7036013Job summarySectorEngineering & ManufacturingSub SectorQuality, TechnicalIndustryHealthcare / PharmaceuticalWhereMedfordContract TypePermanentConsultant nameTaylor RankinJob ReferenceJN-062026-7036013
