Sr. Quality Engineer

Principal Quality EngineerThe Principal Quality Engineer provides technical leadership for quality assurance activities across new product development and sustaining engineering programs. This role ensures products and processes comply with internal quality systems, global regulatory requirements, and industry standards while partnering with cross-functional teams to drive product quality, regulatory compliance, and continuous improvement throughout the product lifecycle.Key ResponsibilitiesServe as the senior Quality Assurance representative for new product development and sustaining engineering projects.Lead design and manufacturing reviews to ensure compliance with Quality Management System (QMS) requirements and applicable regulatory standards.Lead risk management activities, including development and review of DFMEAs, PFMEAs, and risk management documentation in accordance with ISO 14971.Review and approve design control documentation, including design inputs, design outputs, verification and validation protocols, reports, and engineering changes.Provide technical leadership during internal, external, customer, and regulatory audits, including FDA, ISO 13485, and MDSAP inspections.Lead complex CAPA investigations, root cause analyses, and effectiveness verification activities.Drive continuous improvement initiatives using Lean, Six Sigma, and quality engineering principles.Mentor and provide technical guidance to junior QA Engineers and cross-functional project teams.Evaluate quality metrics, complaint trends, nonconforming material, and manufacturing data to identify systemic risks and recommend corrective actions.Partner with Engineering, Manufacturing, Regulatory Affairs, Clinical Affairs, and Operations to ensure product quality throughout the development lifecycle.Develop, review, and maintain quality procedures, work instructions, validation documentation, and quality records.Support supplier quality activities, qualification efforts, and process validation as required.Qualifications & ExperienceBachelor's degree in Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or related technical discipline.5+ years of Quality Assurance experience within the medical device industry or another highly regulated industry.Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971, and applicable international regulations.Demonstrated experience supporting new product development using Design Controls.Experience leading CAPA investigations, internal audits, risk management activities, and quality system improvements.Strong understanding of manufacturing processes, process validation, and statistical analysis techniques.Excellent technical writing, analytical, and problem-solving skills.Strong communication and leadership skills with the ability to influence cross-functional teams.Knowledge and experience with software as a medical device.Independently plan, develop, maintain, and execute comprehensive software verification and validation (V&V) strategies aligned with regulatory and quality requirements.Review and approve software requirements, design documentation, risk management files, and test protocols to ensure completeness, traceability, and compliance.Review and approve detailed test protocols and document objective evidence of test execution consistent with internal procedures and regulatory standards.Perform complex testing activities involving multi-system integrations, data interfaces, interoperability, and performance evaluation.Preferred QualificationsASQ Certified Quality Engineer (CQE), Six Sigma Green Belt/Black Belt, or equivalent certification.Experience supporting FDA inspections, ISO 13485 certification audits, and MDSAP audits.Experience with Design Controls, Process Validation (IQ/OQ/PQ), and software validation.Familiarity with PLM and ERP systems such as Agile PLM, Oracle, SAP, or Windchill.Experience leading global quality improvement initiatives.Knowledge of statistical process control (SPC), validation, and reliability engineering.Skills & AttributesDemonstrated leadership in Quality Engineering and regulatory compliance.Expert knowledge of Quality Management Systems and medical device regulations.Strong risk assessment and problem-solving capabilities.Excellent mentoring and coaching skills.Ability to influence technical decisions across multiple functional groups.Strong project management and organizational skills.Excellent written and verbal communication skills.High attention to detail with a commitment to product quality, patient safety, and continuous improvement.Working ConditionsOffice-based environment with clean, organized, and well-lit workspaceLow to moderate noise levelsPrimarily computer-based work with cross-functional team interactionOccasional standing or extended desk work as requiredPhysical RequirementsAbility to sit or stand for extended periodsRegular use of computer and office equipmentWho We're Looking For:Quality Leader – passionate about ensuring safe and compliant medical devicesDetail-Oriented Professional – committed to precision in documentation and analysisCollaborative Influencer – able to guide cross-functional teams toward quality outcomesAnalytical Thinker – skilled in identifying trends and solving complex problemsAudit-Ready Mindset – comfortable operating in highly regulated environmentsContinuous Improver – focused on strengthening systems, processes, and outcomesCurrently, Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.Creating better together. It's the Enovis purpose, and it's what drives us and empowers us every day on a global scale. We know that the power to create better – for our customers, our team members, and our shareholders – begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.We offer a comprehensive benefits package that includes:Medical InsuranceDental InsuranceVision InsuranceSpending and Savings Accounts401(k) PlanVacation, Sick Leave, and HolidaysIncome Protection PlansDiscounted Insurance RatesLegal ServicesJoin us in creating better together.EQUAL EMPLOYMENT OPPORTUNITY Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.