Manager, Quality Assurance Operations
Posted on: October 8, 2019
As the Manager of Quality Assurance Operations for our largest
manufacturing site of medical devices, you will lead the planning,
coordination and direction of quality support services for three
unique factories. This role is both strategic and tactical. Your
team will include quality engineers who are responsible for
monitoring nonconforming product, analyzing and reporting process
performance data, and assuring the execution of established
procedures. In addition, you will drive continuous improvement
projects as we transform our growing business. In this role, you
will be accountable for making complex and difficult decisions, and
act as back up to the Site QA Lead.
If you are passionate about ensuring the quality and safety of
medical devices, and a strategic, transformational leader who can
inspire your team to raise the bar, please apply now for immediate
Duties and Responsibilities:
* Direct Quality Assurance Operations Team activities by
establishing policies and procedures based on best business
practices, regulatory requirements, and chosen quality system
* Responsible for compliance with all corporate regulatory, human
resource programs, policies, procedures, safety/environmental
systems and regulations governed by local and international
agencies and authorities.
* Plans, coordinates, and directs quality assurance programs to
ensure continuous production of products consistent with
established standards by performing designated duties personally or
* Assist in the processes for the documentation, review, approval,
distribution, and revision control of quality system procedures.
Provide oversight, assess conformance and ensure compliance of
quality system procedures and work instructions with regulatory
requirements and company objectives through application of approval
* Coordinate Quality Assurance activities related to sustaining and
new product development and release. Responsible for reviewing
validations and relate strategies, designs and manufacturing
methods for adherence to quality standards and plan appropriate
controls and product acceptance parameters.
* Assist in the operation and implementation of the corrective and
preventive action system. Provide guidance and support of
corrective and preventive action projects and provide management
feedback on the performance, effectivity, and functioning of the
corrective and preventive action system.
* Coordinate efforts for the establishment of controls supporting
current product designs and process capabilities. Monitor the
performance of product lines with regard to product quality levels,
waste and rejection rates. Responsible for analyzing and assisting
in the resolution of solving issues that prevent desired production
quality level achievement.
* Develop personnel through daily interactions and coaching of
staff, provide guidance to staff in technical and quality assurance
matters and in effective business partnering with Marketing, Sales,
R&D, and Operations. Provide quality assurance training to
other functional teams. Assist in developing training programs to
upgrade the skill levels and compliance of all related
* Enforce safety policies & procedures. Evaluate staff member's
safety performance and ensure that safety is a part of each direct
report's GPMS. Provide resources (time and money) necessary to
maintain safety process. Ensure safety structure is in place in
form of working committees and department coordinators
* Oversee capital related projects and monitor controllable
spending for the department.
* Lead or participate in regulatory agency interaction: FDA (Food &
Drug Administration), BSI, during audits or other information
* Partner with cross-functional leaders to meet goals and
objectives including support to Plant Wide Initiatives.
* Lead Plant/Organizational initiatives driving business
* Ensures compliance with Environmental Management System (EMS)
* Other responsibilities may be assigned & not all responsibilities
listed may be assigned
Work Experience Requirements:
* Minimum 5 years' experience in Medical device, Pharmaceutical or
related regulated industry Quality Assurance in progressively more
* GMP/ ISO knowledge required.
* Understanding of FDA and EU regulatory requirements for design,
manufacture, marketing, and distribution strongly preferred.
* Experience in performing and reporting internal audits
* Bachelor's degree in engineering, science or technical field or
equivalent professional experience.
Preferred Knowledge Requirements / Skill Sets:
* Knowledge or completion of Process Excellence Six Sigma, Lean,
and/or Design Excellence courses or a comparable process for
problem solving/ decision making preferred. Green or Black Belt
Certification highly desired.
* Advanced degree desired. Certifications such as CQE, CQA, CQM,
Six Sigma, Lean Sigma also desired.
This position is not eligible for employer-visa sponsorship
* Competitive compensation
* Excellent healthcare including medical, dental, vision and
* Short & long term disability plus life insurance -- cost paid
fully by CONMED
* Retirement Savings Plan (401K) -- company match dollar for dollar
up to 7% Employee stock purchase plan -- allows stock purchases at
discounted price.Tuition assistance for undergraduate and graduate
CONMED is an Equal Opportunity Employer & an Affirmative Action
Employer. CONMED is a strong advocate of workforce diversity. All
qualified applicants will receive consideration for employment
without regard to race, ethnicity, color, religion, sex, sexual
orientation, gender identity, national origin, disability, or
If you feel you need a reasonable accommodation pursuant to the
ADA, you are encouraged to contact us at 800-325-5900 option #3.
Keywords: CONMED, Largo , Manager, Quality Assurance Operations, Executive , Largo, Florida
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