JobWatch

28 days old

Quality Assurance Manager

Kelly Services
Waco, TX 76702
**Kelly Services is actively recruiting for a Quality Assurance Manager for a Direct Hire opportunity in Waco, Tx.**


**OVERVIEW**


The Quality Assurance (QA) Manager is responsible for ensuring and maintaining the overall effectiveness of the Site Quality Program. This includes but is not limited to the establishment and maintenance of processes and procedures in compliance with ISO 13485 and 21 CFR 820 to ensure that all products meet and maintain regulatory standards and compliance. The QA Manager will function as the Site Management Representative for all interactions with regulatory bodies including but not limited to the FDA (Food and Drug Administration) and ISO (International Standards Organization).



**JOB RESPONSIBILITIES**


+ Responsible for overall effectiveness of Site Quality Program.

+ Function as the Management Representative for all regulatory bodies and agencies.

+ Ensure that the Quality System requirements are effectively established and maintained in accordance with 21 CFR 820

+ Establish Quality Plan which defines quality practices, resources, and activities relevant to Client products that are manufactured.

+ Responsible for establishing Quality System procedures and instructions.

+ Establishment of robust supplier quality initiatives and audits.

+ Establish and maintain Site Internal Audit program and schedule.

+ Oversee MRB (Material Review Board) process.

+ In accordance with 21 CFR 820, Lead Management Review with Senior Management Team within pre-determined intervals.

+ Oversee and manage the Site CAPA (Corrective and Preventative Actions) system.

+ Manage the quality department personnel to ensure that all Quality objectives are completed in a timely manner.

+ Responsible for management of both receiving inspection as well as production inspection processes.

+ Ensure compliance with cGMP standards.

+ Uphold all elements of the Site Quality Policy.

+ Other duties which may be assigned from time to time at this, or other facilities of Client.


**KNOWLEDGE, SKILLS, and ABILITIES**


+ High level of organizational skill is required.

+ Ability to work independently, in a fast paced, high-pressure environment.

+ Advanced knowledge of ISO 13485 as well as 21 CFR 820

+ Advanced knowledge of Microsoft Excel, Word, and Outlook.

+ Advanced communication and problem-solving skills.


**REQUIREMENTS**


+ 4-year college degree (Bachelors) in Science, or equivalent.

+ 5+ years experience in regulatory affairs, product development, or product manufacturing in a Management capacity.

+ Six Sigma Certification a plus

+ Lean Manufacturing Certification a plus

+ ISO Lead Auditor Certification a plus


**If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.**


**\#TJP2022_SPEC**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-05-30 Expires: 2022-06-30

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Quality Assurance Manager

Kelly Services
Waco, TX 76702

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