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Manager, Quality Assurance Operations

Company: CONMED
Location: Largo
Posted on: October 8, 2019

Job Description:

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 consideration.

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 standards requirements.

* 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 through subordinates.
* 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 authority.
* 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 personnel.

* 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 inquiries.
* Partner with cross-functional leaders to meet goals and objectives including support to Plant Wide Initiatives.
* Lead Plant/Organizational initiatives driving business performance.
* Ensures compliance with Environmental Management System (EMS) responsibilities.
* 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 responsible positions.

* 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 preferred.

Education Requirements:

* 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.

Travel: 0-20%

This position is not eligible for employer-visa sponsorship

CONMED offers

* Competitive compensation

* Excellent healthcare including medical, dental, vision and prescription coverage

* 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 level courses

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 veteran status.

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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