Job Description:
At Enovis™ 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 Assurance 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.
Job Title:
Quality Assurance Engineer
Reports To:
Quality Assurance Manager
Location:
Vista, CA
Business Unit Description:
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Bracing and Supports
Role Summary:
We are in search of a highly motivated and experienced Quality Assurance Engineer to join our team. The Quality Assurance Engineer will be responsible for implementing and overseeing activities at our company's manufacturing location. This role will be responsible for ensuring the quality and reliability of our products and processes. The ideal candidate should have a strong background in quality management, as well as excellent leadership and communication skills.
The ideal candidate will possess extensive knowledge of engineering and problem-solving principles and be accountable for a wide range of complex activities related to designing, implementing, and maintaining quality assurance protocols and methods. The Quality Assurance Engineer will ensure external safety, quality, and compliance with the most complex company standards and government regulations.
Key Responsibilities:
The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet the business need.
- Develop, implement, and maintain Master Quality Plan
- Facilitate quality improvement through data collection, control charting, and experimental design techniques.
- Participate in the Master Validation Plan (IQ, OQ, PQ) for validation processes.
- Lead continual improvement activities such as 5S and Kaizen lean methods.
- Develop and conduct training programs for quality awareness.
- Interface with Engineering and Operations to ensure product changes aligns with approved data.
- Support Quality Inspectors/Techs to ensure compliance with the quality management system.
- Conduct audits and analyze failure, corrective, and preventive actions.
- Create and maintain company quality documentation.
- Organize and manage receiving/outgoing quality functions.
- Drive continuous improvements and manage Nonconformances.
- Resolve customer and internal quality concerns using problem-solving techniques.
- Work on DOE projects and manage Gage R&R, SPC, and Capability requirements.
- Participate in Launch and Current Production Engineering Changes.
- Support Lean initiatives and review of Daily and Weekly Quality performance Scorecards.
- Ensure a safe work environment and compliance with safety and environmental regulations.
- Evaluate nonconforming material and recommend updates to quality standards.
- Assure product compliance with internal or external specifications and standards.
- Analyze trends in device failures and lead root cause analysis.
- Support Manufacturing and Operations to resolve quality or compliance issues.
- Serve as a subject matter expert for quality in audits.
- Author procedures and work instructions for the quality system
- Conduct internal audits and support complex special projects as assigned.
Minimum Basic Qualifications
- Bachelor's degree in science or engineering and 5 plus years of applicable experience (CQA or CQE certification preferred).
- Bilingual Spanish/English preferred.
- Certification to perform audits is required (certification may be obtained through successful completion of an auditor course or CQA, or on-the-job training by another qualified internal auditor).
- Proficiency in Medical Device engineering standards and concepts, along with knowledge of FDA/GMP, CMDR, MDR, MDSAP, and ISO quality standards.
- Basic knowledge of manufacturing processes (and associated tools, instruments, and test equipment) including inspection, machine shop technology, polish/grind, and clean room technology.
- Proficient in Microsoft Word (or equivalent word processing software) and Excel (or equivalent spreadsheet software). Statistical analysis and database searches.
- Competent working knowledge of US and International quality system regulations.
- Proven project management skills.
Travel Requirements:
- Up to 10%
Desired Characteristics:
- Desired Characteristics:
- Preferred knowledge of the following software packages: Microsoft, Minitab, Oracle R12, Agile PLM.
- Prefer CQE, Lean, or 6 Sigma Certification.
- Detail oriented and analytical.
Physical Requirements:
- Ability to sit/stand for long periods of time.
- Ability to lift/pull/carry up to 25lbs
"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 on creating the next generation of better together at Enovis:
Better is... | Enovis
We offer a comprehensive benefits package which includes:
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Spending and Savings Accounts
- 401(k) Plan
- Vacation, Sick Leave, and Holidays
- Income Protection Plans
- Discounted Insurance Rates
- Legal Services
ABOUT ENOVIS
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. Visit www.enovis.com to learn more.
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.
ABOUT ENOVIS™
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.
EOE AA M/F/VET/Disability Statement
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.