Manager, Quality Assurance - Houston, United States - Enovis

Enovis Houston, United States

1 week ago

Description

Job Description:
At EnovisTM 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.

As the Quality Manager you will provide technical and administrative guidance to Quality Assurance, Quality Control, Manufacturing, and Suppliers of sourced product.

Assures product conformance to established requirements and standards through appropriate inspection and test activities. Coordinates quality planning, inspection method development and defect prevention/corrective action processes for new and existing products. Identifies and solves product and process problems and supports various operational groups. Assists in the preparation and monitoring of the operating and capital budgets.

Essential Duties and Responsibilities:
The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet the business need.
Lead incoming inspection and operations quality engineering teamsUtilizing 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 company standards and government regulationsThis position supports the incoming inspection department and works closely with suppliers and internal teams to reduce inspection burden while ensuring high product qualitySupervise inspection personnel and formulate strategy to increase efficiencies in QC DepartmentSupervise QA engineers responsible for supplier inspection and supporting internal manufacturingAssist the prioritization of daily schedules and work activitiesReview inspection strategies and techniques used on implant and instrument productReview inspection equipment programs for suitabilityAble to perform inspection activities to support team, as neededPartner with suppliers to develop inspection requirements to an extent that they are certified and able to perform the final inspection (dock-to-stock, skip lot)

Author and execute supplier inspection certifications and validationsAssist process capability for product qualifications to reduce inspection within manufacturing and inspection areasSupport manufacturing to correct adverse quality or compliance issuesSupport and engage in quality system activities (e.g., management review, CAPA, design control, process control, change control, document control, label control) that ensure products conform to defined requirementsSupport regulatory inspections and verify that appropriate follow-up and corrective actions are developed and implementedFoster a positive employee environment by promoting open communication, engagement and development of team membersPromotes a culture of trust, flexibility, teamwork and inclusion, ensuring all relevant functions are included in decision making processes as part of continuous improvement, problem solving and projectsCreate a highly talented team by recruiting, hiring, and developing individuals in positions aligned with their future potential.

Ensures effective training and performance management of the teamsWork closely and develops strong business relationships with key stakeholders in operations, commercial, and engineering management teams to help drive business successDetermine and define quality assurance requirements from review of engineering drawings and/or specifications, industry standards, government specifications or other applicable source documentsFormulate and maintain procedures, specifications, and standards for the quality control of products including; non-destructive testing methods, gauge design and procurement, sampling and inspection methods, and visual acceptance standardsCoordinate the maintenance of the calibration program for all inspection tools and gauges to comply with division and corporate Good Manufacturing PracticesDevelop and administer effective data collection and reporting system to meet regulatory requirementsResponsible for ensuring the control of nonconforming products until deficiency or unsatisfactory condition has been correctedProvide resources, including the assignment of trained personnel, for performance of work and assessment activities to meet requirementsImplement defect prevention strategies utilizing SPC/SQC principles and practicesRequired Education and Experience:

Bachelor's degree in engineering or related discipline with a minimum of 4+ years of work experience within a quality function2+ years of supervision/leadership experienceBackground in Medical Device, Aeronautics, Automotive or other highly regulated industry required; preferred knowledge of ISO 13485 quality standardsFamiliar with quality control methods, including; non destructive testing, metrology, statistical processcontrol, calculating quality costs, and inspection report creationAbility to use inspection measuring equipment, including: calipers, micrometers, gages, and othercomputerized measuring equipment (CMM, Oasis, Vision X, Keyence) is a plusBasic knowledge of manufacturing processes: key focus into metrology, precision machining, grinding,product cleaning, and sterilizationRequired and demonstrated knowledge of Microsoft Office SuitePreferred knowledge of the following software packages: Solidworks, NetSuite, Agile PLM.

Quality discipline certifications a plus, including:

CQE, CQA, Lean, 6 Sigma Certification (Green orYellow Belt), or experience and knowledge of continuous improvement methodology"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 video and discover what creating better together means to us at Enovis:
Our Enovis Purpose, Values and Behaviors on VimeoWe offer a comprehensive benefits package which includes:Medical InsuranceDental InsuranceVision InsuranceSpending and Savings Accounts401(k) PlanVacation, Sick Leave, and HolidaysIncome Protection PlansDiscounted Insurance RatesLegal ServicesABOUT ENOVISEnovis 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 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 ENOVISTMEnovis 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.

For more information about Enovis, please visit AA M/F/VET/Disability StatementAll 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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