QA Compliance Specialist

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,