Associate Manager, Quality Engineering

Who We Are

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 Companys extensive range of products services and integrated technologies fuels active lifestyles in orthopedics and more information about Enovis please visit .

What Youll Do

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 thats how we change the lives of patients for the better. And thats how we create better together. Why work at Enovis See for yourself .

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:
Associate Manager Quality Engineering

Reports To:
Associate Director Quality Engineering

Location:
Austin Texas

Business Unit Description:
Quality Assurance

Job Title/High-Level Position Summary:

The Associate Manager Quality Engineering provides day-to-day leadership technical guidance and support to the Quality Engineering team while remaining actively involved in supporting manufacturing operations. This role serves as a key quality partner to Manufacturing and Operations supporting and leading quality investigations Material Review Board (MRB) activities continuous improvement initiatives and quality system compliance. The Associate Manager also supports the leader of quality with team priorities employee development and execution of departmental objectives.

Key Responsibilities:

• Provide day-to-day technical guidance direction and support to Quality Engineers and other Quality team members.
• Assist in managing team priorities resource allocation employee development and execution of departmental objectives to ensure business and quality goals are achieved.
• Manage and supervise assigned Quality Engineering personnel including performance management coaching training development planning and employee engagement activities.
• Coach and develop team members through regular feedback technical guidance and development opportunities.
• Serve as a key Quality partner to Manufacturing and Operations providing timely support for production and quality-related issues.
• Lead and facilitate risk-based decision making regarding manufacturing deviations process changes supplier-related quality issues and product quality concerns.
• Lead and support Material Review Board (MRB) activities including evaluation and disposition of nonconforming material.
• Monitor production and quality data communicate key metrics identify emerging risks and trends and escalate significant quality concerns as appropriate.
• Lead root cause and CAPA investigations using structured problem-solving methodologies and ensure corrective actions are implemented and verified for effectiveness.
• Lead or support process and equipment validations including IQ/OQ/PQ/TMV and review and approve related protocols reports and engineering documentation.
• Lead or support supplier quality activities including supplier investigations Supplier Corrective Action Requests (SCARs) supplier performance monitoring supplier transfers and supplier change management activities.
• Develop and recommend updates to quality standards procedures work instructions and processes.
• Monitor and drive site quality metrics including FPY NCMRs CAPA effectiveness complaint trends and audit performance. Develop action plans to address adverse trends.
• Support compliance with applicable internal requirements and regulatory standards including GMP FDA requirements and ISO 13485.
• Review trends related to scrap nonconforming material process deviations and device failures to identify systemic quality concerns.
• Partner cross-functionally with Manufacturing Engineering and Operations to resolve quality issues and support manufacturing transfers new product introductions process changes and continuous improvement initiatives.
• Participate in internal external and regulatory audits and support timely resolution of audit observations.
• Promote a culture of quality accountability collaboration and continuous improvement and lead complex projects and quality initiatives as assigned.

Minimum Basic Qualifications:

• Bachelors degree in Engineering Science or a related technical discipline required.
• 5 years of Quality Engineering Manufacturing Engineering or related experience within a regulated manufacturing environment.
• Experience within Medical Device Aerospace Automotive or another highly regulated manufacturing industry required; medical device manufacturing experience strongly preferred.
• Previous experience leading projects mentoring employees serving as a technical lead or providing day-to-day direction to a team.
• Experience with manufacturing transfers and process/equipment validation including IQ/OQ/PQ required.
• Demonstrated experience with root cause analysis CAPA nonconforming material and structured problem-solving methodologies.
• Strong technical writing skills with demonstrated ability to develop review and approve quality documentation.
• Working knowledge of manufacturing processes with emphasis on areas such as metrology precision machining grinding product cleaning and sterilization.
• Proficiency with Microsoft Office applications including Excel Word and PowerPoint.

Desired Characteristics:

• Working knowledge of FDA Quality System requirements GMP and ISO 13485 standards preferred.
• CQE CQA Lean Six Sigma or similar quality certification preferred.
• Demonstrated ability to provide guidance coach and develop employees while maintaining strong collaborative relationships.
• Ability to balance technical responsibilities team support and changing operational priorities.
• Strong judgment with the ability to identify and appropriately escalate significant quality compliance or business risks.
• Ability to influence and collaborate effectively across functions and organizational levels.
• Strong analytical and problem-solving skills with the ability to make sound data-driven decisions.
• Excellent written and verbal communication skills including the ability to communicate complex technical issues to both technical and non-technical audiences.
• Strong organizational skills and ability to manage multiple priorities in a fast-paced manufacturing environment.
• Demonstrated commitment to quality accountability customer service and continuous improvement.
• Professional judgment ethics and demeanor.
• Position is office/manufacturing-site based in Austin Texas.
• Must be able to lift up to 50 lbs.
• Must be able to bend twist and lift overhead.
• Must be able to communicate clearly and fluently in English both verbally and in writing.

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.

Creating better together. Its the Enovis purpose and its 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:

We offer a comprehensive benefits package that 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

Join us in creating better together.

EQUAL EMPLOYMENT OPPORTUNITY
Enovis provides equal employment opportunities based on merit experience and other work-related criteria 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.

Required Experience:

Manager