Quality Assurance Engineer – Inspection and Sustaining

Job Description:

At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients, and take pride in the pursuit 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. Why work at Enovis? See for yourself.

As a key member of the Quality 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 and Sustaining

Reports To:

Sr. Director, Quality

Location:

Houston Plant

Business Unit Description:

Foot and Ankle

High-Level Position Summary:

We are seeking a skilled and experienced Quality Assurance Engineer to join our team. The QE - Inspection and Sustaining provides quality support to quality control and reviews product changes to commercialized devices. Focus on inspection reduction initiatives while managing risk and ensuring high product quality

Key Responsibilities: The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet the business need.

• Review inspection strategies and inspection techniques used by Enovis on implant and instrument product

• Write inspection plans, CMM programs, and vision system programs

• 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 review protocols and reports related to design changes and supplier transfers

• Conduct process capability PQs to reduce inspection

• Investigate customer complaints

• Support Manufacturing and Operations to remedy adverse quality or compliance situations

Currently, Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.

Minimum Basic Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Bachelor’s in Engineering and 5+ years of experience

• Background in Medical Device of other highly regulated industry

• Knowledge of ISO 13485, ISO 14971, and FDA regulations

• Advanced knowledge of mechanical inspection and associated inspection equipment

• Requires basic knowledge of manufacturing processes: metrology, machining, product cleaning, and sterilization

• Individual should have knowledge of Microsoft Office Suite

• Travel up to 10% as needed

Work environment | Physical demands:

• The office space is clean, orderly, and properly lighted and ventilated. Noise levels are considered low to moderate.

• The manufacturing floor provides direct exposure to manufacturing equipment and hazards. Noise levels are considered moderate to high.

• Ability to sit and stand for long periods of time.

• Ability to lift and carry 25 pounds.

• Ability to tug, pull, or lift up to twenty-five (25) pounds.

Desired Characteristics:

• Preferred knowledge of CMM programming in PC-DMIS

• Familiarity with vision system programming

• Prefer CQE, Lean, or 6 Sigma Certification

• Ability to work and multi-task with little supervision

• Ability to articulate clearly, professional oral and written communication skills

“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.

What does creating better together mean to us at Enovis? Discover the “why” behind our purpose, values and behaviors: