1 день назад
Principal Quality Engineer - CST - Memphis, TN (Onsite)
120 800 - 181 200$
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Описание вакансии
Текст:
TL;DR
Principal Quality Engineer (Medical Devices): Leading quality strategy, compliance, supplier quality, and lifecycle activities for cranial and spinal technologies with an accent on regulated product development and manufacturing. Focus on design history files, risk management, quality investigations, manufacturing transfers, supplier audits, and process validation.
Location: Memphis, Tennessee, United States; onsite with a minimum of four days per week in the office. Travel is expected to be less than 20%.
Salary: $120,800–$181,200 per year, plus eligibility for a short-term incentive plan.
Company
develops healthcare technologies for neurological, spinal, chronic pain, and other medical applications.
What you will do
- Lead quality strategy and quality engineering activities across product development, manufacturing, and lifecycle management for cranial and spinal technologies.
- Develop and maintain quality standards, protocols, quality records, design history files, risk management documentation, and change controls.
- Partner with engineering, operations, manufacturing, supplier quality, regulatory affairs, and external manufacturing sites to ensure product and quality-system compliance.
- Lead inspections, testing, product acceptance, performance reviews, production parts approval, nonconformance investigations, and corrective and preventive actions.
- Lead manufacturing transfers, continuous improvement initiatives, supplier audits, and process validations.
- Mentor junior engineers and serve as the quality engineering subject matter expert during internal and external inspections.
Requirements
- Bachelor’s degree in mechanical engineering, industrial engineering, or another engineering discipline with at least 7 years of engineering experience, or an advanced degree with at least 5 years of medical device industry experience.
- Experience in quality engineering within a regulated manufacturing or product development environment.
- Experience applying quality management system requirements and supporting regulatory compliance.
- Experience leading cross-functional projects, investigations, or quality improvement initiatives.
- U.S. work authorization is required; sponsorship is offered for Principal-level roles and above.
Nice to have
- Medical device experience across multiple quality management systems and Certified Quality Auditor certification.
- Experience with blueprint reading, GD&T, metal machining, metrology, and statistical analysis tools.
- Knowledge of FDA, ISO, IEC, and EU MDR requirements.
- Lean Six Sigma certification and process improvement experience.
Culture & Benefits
- Health, dental, and vision insurance, plus health and flexible spending accounts.
- Life insurance, disability coverage, paid time off, and paid holidays.
- 401(k) plan with employer contribution and match.
- Tuition assistance or reimbursement, employee stock purchase plan, and employee assistance program.
- Incentive plans and a global well-being program.
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