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:

• 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.

• 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.

• Up to 10%

• 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.

• Ability to sit/stand for long periods of time.
• Ability to lift/pull/carry up to 25lbs

• 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