Manager, Quality Assurance
Company: Enovis
Location: Houston
Posted on: April 16, 2024
Job Description:
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.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
teams
- 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 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
- Supervise inspection personnel and formulate strategy to
increase efficiencies in QC Department
- Supervise QA engineers responsible for supplier inspection and
supporting internal manufacturing
- Assist the prioritization of daily schedules and work
activities
- Review inspection strategies and techniques used on implant and
instrument product
- Review inspection equipment programs for suitability
- Able to perform inspection activities to support team, as
needed
- Partner 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
validations
- Assist process capability for product qualifications to reduce
inspection within manufacturing and inspection areas
- Support manufacturing to correct adverse quality or compliance
issues
- Support 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 requirements
- Support regulatory inspections and verify that appropriate
follow-up and corrective actions are developed and implemented
- Foster a positive employee environment by promoting open
communication, engagement and development of team members
- Promotes 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 projects
- Create 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 teams
- Work closely and develops strong business relationships with
key stakeholders in operations, commercial, and engineering
management teams to help drive business success
- Determine and define quality assurance requirements from review
of engineering drawings and/or specifications, industry standards,
government specifications or other applicable source documents
- Formulate 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
standards
- Coordinate the maintenance of the calibration program for all
inspection tools and gauges to comply with division and corporate
Good Manufacturing Practices
- Develop and administer effective data collection and reporting
system to meet regulatory requirements
- Responsible for ensuring the control of nonconforming products
until deficiency or unsatisfactory condition has been
corrected
- Provide resources, including the assignment of trained
personnel, for performance of work and assessment activities to
meet requirements
- Implement 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
function
- 2+ years of supervision/leadership experience
- Background in Medical Device, Aeronautics, Automotive or other
highly regulated industry required; preferred knowledge of ISO
13485 quality standards
- Familiar with quality control methods, including; non
destructive testing, metrology, statistical process
- control, calculating quality costs, and inspection report
creation
- Ability to use inspection measuring equipment, including:
calipers, micrometers, gages, and other
- computerized measuring equipment (CMM, Oasis, Vision X,
Keyence) is a plus
- Basic knowledge of manufacturing processes: key focus into
metrology, precision machining, grinding,
- product cleaning, and sterilization
- Required and demonstrated knowledge of Microsoft Office
Suite
- Preferred knowledge of the following software packages:
Solidworks, NetSuite, Agile PLM.
- Quality discipline certifications a plus, including: CQE, CQA,
Lean, 6 Sigma Certification (Green or
- Yellow 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 Insurance
- Dental Insurance
- Vision Insurance
- Spending and Savings Accounts
- 401(k) Plan
- Vacation, Sick Leave, and Holidays
- Income Protection Plans
- Discounted Insurance Rates
- Legal 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 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 more information about
Enovis, please visit EOE 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.
Keywords: Enovis, League City , Manager, Quality Assurance, Executive , Houston, Texas
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