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Qa • columbus oh
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Job Title : QA Compliance Specialist
Location : Columbus, OH 43219
Contract Duration : 12+ Months Contract with possibility to extend
Core Job Responsibilities
- The QA Compliance Specialist position exists to support the execution of quality & regulatory functions in the organization to ensure compliance of the AV-SH quality / business systems to applicable regulations, standards and corporate policies.
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Support external audit activities (FDA, FDB, ISO registrar audits etc.).
- Audit areas of Vascular Quality System.
- Support administration of Quality System processes (CAPAs, Internal Audits etc.).
- Generate and distribute periodic open CAPA and Internal Audit Corrective Action (IACA) reports.
- Track and trend compliance activities on a periodic basis. This may include CAPA & IACA metrics etc. Generate compliance metrics for Management Reviews.
- Assist the organization to receive timely feedback on open corrective actions.
- Participate in cross divisional activities to integrate quality system information. 8. Conduct review and update Quality System procedures as necessary.
- Assist in developing & conducting Quality System training as necessary.
- File Quality Records (audit reports, IACAs, CAPAs etc.).
- Ensure that all responsibilities are carried out in compliance with governing regulations and standards.
- Other duties as assigned. Bachelor Degree or equivalent plus 4 + years of related work experience or equivalent combination.
About Kyyba :
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.
Disclaimer :
Kyyba is an Equal Opportunity Employer.
Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need.
Rewards :
Medical, dental, vision
401k
Term life
Voluntary life and disability insurance
Optional Pre-paid legal plan
Optional Identity theft plan
Optional Medical and dependent FSA
Work-visa sponsorship
Opportunity for advancement
Long-term assignment with opportunity for hire by client
Select Awards
Thanks & Regards,