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  • 1 week ago

jobs description

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a direct hire opportunity to work as a Quality Operations Manager located in Warren, NJ .

Shift: Monday-Friday, first shift, onsite...

Pay: $90k max (salary dependent on experience)

The Manager of Quality Operations leads a team of quality specialists and ensures that product is produced that meets design specifications, quality system requirements, and regulatory requirements. This is a hands-on manager role that is directly involved with day-to-day operations required to produce medical device products.

Key Accountabilities:
• Maintain quality system compliance with ISO 13485, QSR, IVDR, CMDR, MDSAP, and any other applicable global regulations. Remaining up-to-date on current and upcoming regulations and guidances.
• Support manufacturing via review and approval of Root Cause Investigations, deviations and nonconformances.
• Provide on-going feedback to all functional groups to improve product quality and compliance throughout the design and manufacturing of products.
• Oversight and coordination of the Change Control and CAPA (deviation, NCMR, OOS, CAPA) programs. Provide guidance to area owners on completion of action items. Interact with site management as necessary to accomplish project goals and objectives.
• Participate in the development, planning and implementation of reagents, assays, software and hardware life cycle management for automated instrumentation and qualification of new/revised test methods, equipment and product/process validation initiatives related to manufacturing.
• Overall responsibility for Quality Operations approval of Design Transfer activities from R&D to Manufacturing, inclusive of production and manufacturing process qualifications.
• Assist the Quality Management Representative in escorting and providing information to Regulatory officials during external audits. Support supplier and internal audits, as needed.
• Manage the new hire and ongoing training programs for quality-related subjects. Manage personnel attendance and perform employee appraisals and competency evaluations as required.
• Manage the QA review and approval of incoming material, labeling, line opening/closing, in-process and finished device history records, including BASIS release and ERP transactions
• Support the QA review and approval of product, process, facility and equipment validation protocols and reports following current quality management system requirements
• Manage the QA storage locations for all quarantine and retains in accordance with associated procedures
• Manage the trending of metrics related to the Quality Management System and share with site management

Qualifications:

Minimum Knowledge & Experience required for the position:
• Bachelors degree in a science related field (biology, chemistry, biomedical, etc)
• A minimum of five (5) years experience in medical device, IVD (in-vitro diagnostics), and/or pharmaceutical experience required
• Two(2) or more years experience in a quality management role, managing a team of 3 or more team members.
• Extensive knowledge of Quality System Regulations (QSR). Working knowledge of 21 CFR 820, ISO 13485, EU IVDR, CMDR
• Proficiency in MS Office
• Experience with an eQMS is preferred (i.e. TrackWise or MasterControl)
• Strong consultative and interpersonal skills
• Ability to prioritize and multi-task
• Strong attention to detail and ability to summarize and communicate at all levels of the organization
• Team player (displays enthusiasm, confidence & commitment)
• Exceptional communication ability (verbal & written)
• Strong presentation skills. Facilitation and Leadership skills
• Ability to take initiatives and work independently
• Strong problem solving and analytical skills

APPLY NOW FOR IMMEDIATE CONSIDERATION!!

#P2

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.
Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment
Warren NJ United States

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