QA Compliance Specialist - KYYBA, Inc
Columbus, OH 43219
About the Job
Job Description
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. 1. Support external audit activities (FDA, FDB, ISO registrar audits etc.). 2. Audit areas of *** Vascular Quality System. 3. Support administration of Quality System processes (CAPAs, Internal Audits etc.). 4. Generate and distribute periodic open CAPA and Internal Audit Corrective Action (IACA) reports. 5. Track and trend compliance activities on a periodic basis. This may include CAPA & IACA metrics etc. Generate compliance metrics for Management Reviews. 6. Assist the organization to receive timely feedback on open corrective actions. 7. Participate in cross divisional activities to integrate quality system information. 8. Conduct review and update Quality System procedures as necessary. 9. Assist in developing & conducting Quality System training as necessary. 10. File Quality Records (audit reports, IACAs, CAPAs etc.). 11. 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 /Veteran Spouses/ 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
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. 1. Support external audit activities (FDA, FDB, ISO registrar audits etc.). 2. Audit areas of *** Vascular Quality System. 3. Support administration of Quality System processes (CAPAs, Internal Audits etc.). 4. Generate and distribute periodic open CAPA and Internal Audit Corrective Action (IACA) reports. 5. Track and trend compliance activities on a periodic basis. This may include CAPA & IACA metrics etc. Generate compliance metrics for Management Reviews. 6. Assist the organization to receive timely feedback on open corrective actions. 7. Participate in cross divisional activities to integrate quality system information. 8. Conduct review and update Quality System procedures as necessary. 9. Assist in developing & conducting Quality System training as necessary. 10. File Quality Records (audit reports, IACAs, CAPAs etc.). 11. 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 /Veteran Spouses/ 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
- An INC 5000 company for 10 years
- Corp! Michigan Economic Bright Spots
- Crain’s Detroit Business Top Staffing Service Companies in Detroit
- TechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions
- Best of MichBusiness winner in HR Wizards & Partnerships
- Metro Detroit Elite Category: Recruitment, Selection & Orientation for 101 Best & Brightest
- 101 Best & Brightest Companies to Work for in Michigan
Source : KYYBA, Inc
