Design Quality Engineering Manager-Surgical
2 weeks ago
Job Description:
At EnovisTM we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence — with the goal of transforming medical technology as we know it.
Because that's how we change the lives of patients for the better. And that's how we create better together.
As a key member of the Quality Engineering team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.
Duties and Responsibilities:
Lead a team of quality engineers responsible for design controls, risk management, V&V strategy, and design transfer for orthopedic implants and instrumentsWork with the project management office to allocate resources and prioritize business needsParticipate in design and manufacturing reviewsGenerate DFMEAs/UFMEAs and participate in risk analysis discussionsReview and approve design and development documentationServe as subject matter expert for design quality in ISO and FDA auditsAuthor procedures and work instructions that define and govern areas of the quality systemEvaluate and disposition nonconforming materialWorking on complex orthopedic and quality system projects as assignedHas typical authority of a manager including hiring, coaching, and terminatingMinimum Qualifications:
Bachelor's in Biomedical or Mechanical Engineering and 5+ years of experienceBackground in medical devices and knowledge of ISO 13485 and 14971 standardsPreferred Qualifications:
Supervisory experience desiredKnowledge of technical writing quality and best practices"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.
Watch this short video and discover what creating better together means to us at Enovis:
We offer a comprehensive benefits package which includes:
Medical InsuranceDental InsuranceVision InsuranceSpending and Savings Accounts401(k) PlanVacation, Sick Leave, and HolidaysIncome Protection PlansDiscounted Insurance RatesLegal ServicesABOUT ENOVIS
EQUAL EMPLOYMENT OPPORTUNITY:
Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and 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.
Supervisory experience desiredABOUT ENOVISTM
EOE AA M/F/VET/Disability Statement
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