Kelly Services Quality Assurance (QA) Manager in Tustin, California

Quality Assurance (QA) Manager (Sterilization Technology) — Tustin, CA

Reporting to the General Manager, the Quality Assurance (QA) Manager is directly responsible for managing and coordinating all quality functions for a sterilization facility. The position will maintain responsibility for all aspects connected with Quality Assurance and Compliance, including the development, analysis and reporting of support data for Regulatory Agencies and Corporate Quality. They will also be responsible for addressing all Quality issues in a timely fashion and communicating that information to the site.

Job Duties and Responsibilities:

  • Quality, Regulatory & Safety

  • Maintains compliance with all regulatory requirements to include: FDA, OSHA, EPA, USDA and NRC as applicable.

  • Actively pursues continuous process and quality improvement as measured by internal indices and external audits/reports.

  • Coordinates activities relating to determining and reporting causes of non-conformances, as well as implementing corrective actions and process improvements; assist in appropriate retraining.

  • Initiates and/or oversees change control process.

  • Analysis of facility data for identification of trends and initiation of required actions.

  • Coordinates all activities relevant to FDA, ISO, customer, Internal & other regulatory audits.

  • Conducts internal compliance audits as required and maintains appropriate records.

  • Coordinates and maintains personnel dosimetry records.

  • Coordinates with plant Operations all system requalification activities as applicable.

  • Assists Corporate Quality Assurance with special projects and assignments as requested.

  • Coordinates facility management reviews and maintains facility risk analysis.

  • Coordinates environmental monitoring and maintains personnel badge testing records.

  • Executes Equivalency and Retrospective Revalidation studies/report where applicable.

  • Operations

  • Coordinates/executes process validations and calibrations where required.

  • Reviews and releases batch records for processed materials.

  • Assists where necessary in establishing departmental objectives to meet overall facility goals.

  • Human Resources

  • Communicates the company quality policy and values, motivating and sensitizing employees to the critical nature of our service, and maintains quality training programs.

  • Involved in the hiring, retention, motivation and development of qualified personnel in QA/Validations positions, if applicable.

  • Assists with new employee orientation, job function, GMP, safety and developmental training to employees as required by Standard Operating Procedures, Certification programs, corporate requirements and customer service initiatives.

Job Requirements:

  • Bachelor's degree (BS), preferably within a Science-related field.

  • Three (3) to five (5) years of quality assurance experience in the medical services/products area or sterilization services areas.

  • Extensive quality science training (e.g., ASQ) with a proven understanding of people’s motivation and leadership potential.

  • Excellent written and verbal communication skills.

  • Above average computer skills.

Apply Today! Questions? Call Justin at 714.602.1217 or email your resume to justin.lynn@kellyscientific.com

Why Kelly ® ?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—

providing you with opportunities to work on today’s most challenging, research-intensive, and relevant

projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help

advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000

scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world

a better place. Let Kelly fuel your career—connect with us today.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect

with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,

Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is

committed to employing a diverse workforce. Equal Employment Opportunity

is The Law.