Quality Assurance Engineer – Inspection

Job Description

If the following job requirements and experience match your skills, please ensure you apply promptly.

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 Inspection Focus

Reports To

Quality Manager Metrology and Quality Control

Location

Austin, TX

Business Unit Description

US Surgical

Job Title / High Level Position Summary

• Utilizing comprehensive knowledge of engineering and problem-solving principles, this position is responsible for a variety of complex activities regarding the design, implementation, and maintenance of quality assurance procedures and work instructions to ensure external safety, quality, and compliance with complex Company standards and government regulations.
• This position supports the incoming inspection department and works closely with suppliers and internal teams to reduce inspection burden while ensuring high product quality.

Key Responsibilities

• Review inspection strategies and inspection techniques used by Enovis on implant and instrument product
• Review CMM programs for suitability
• Partner with suppliers to develop their inspection to an extent that they are certified to perform the final inspection in lieu of Enovis
• Author and execute supplier inspection certifications and validations
• Conduct process capability PQs to reduce inspection
• Analyzing protocols and reports to ensure quality system requirements are met
• Support Manufacturing and Operations to remedy adverse quality or compliance situations
• Working on complex special projects as assigned

Minimum Basic Qualifications

• Bachelor’s in Science or Engineering and 3+ years of experience.
• Background in Medical Device, Aeronautics, Automotive or other highly regulated industry required; preferred knowledge of ISO 13485 quality standards.
• Knowledge of technical writing quality and best practices.
• Required basic knowledge of manufacturing processes : key focus into metrology, precision machining, grinding, product cleaning, and sterilization.
• Individual should have knowledge of Microsoft Office Suite of software or equivalent.

Travel Requirements

Up to 10%

Desired Characteristics

• Knowledge of CMM programming
• Preferred knowledge of the following software packages : Solidworks, Solidworks ePDM, Oracle R12, Agile PLM, and PC-DMIS
• Prefer CQE, Lean, or 6 Sigma Certification.
• Advanced knowledge of mechanical inspection and the associated inspection equipment
• Detail oriented and analytical

Physical Requirements

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

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

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.

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.

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