Senior QRA Specialist

  • Company:
    Cardinal Health
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    15 hours ago
  • Category:
    General

**ESSENTIAL DUTIES AND RESPONSIBILITIES:**

With minimal supervision, responsible for the following Quality & Regulatory activities:

+ Advocate for Quality and Compliance within the organization and provide advice on Quality related matters to all functional areas
+ Assist with Audits of internal functions/processes, external 3rd party service provides, such as but not limited to Logistic Service Partners, 3rd party Service & Repairs Vendors.
+ Assist in creating and maintaining internal audit schedules and records including tracking CAPA activities as required
+ Write, review and revise local Quality System procedures including Supplier Quality agreements, Change Request, SOP’s & WI Responsible for supplier management process from the Quality perspective which include supplier qualification such as on-site audits, supplier survey etc and maintenance through Evaluation of supplier quality performance and conducts periodic evaluations/audit of suppliers as required
+ Support Internal Technical Solutions (Service & Repairs) workshop to comply to ISO 13485 & Cardinal Health requirements
+ Primary point of contact for coordination of Quality Hold, stop shipments and authorising product release – liaise with global QA team, local logistics/supply. Review and investigate customer complaints, ensure adverse events are reported in a timely manner to the relevant regulatory authorities
+ Assist RA/QA Manager with Quality Systems training to staff
+ Ensure personal and company compliance with all local and company regulations, policies, and procedures
+ Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable Markets
+ Perform other RA/QA duties assigned as needed

**EDUCATION/TRAINING and/or EXPERIENCE:**

+ Minimum 4-6 years’ experience in Medical Device Industry
+ Bachelor’s Degree in Science/Pharmacy/Bioengineering

**REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:**

+ Must be familiar with MS Office applications
+ Excellent communication skills (verbal and written)
+ Project management skills
+ Problem solving skills
+ Presentation skills

**ADDITIONAL POSITION REQUIREMENTS**

+ Travel: 15%

_Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status._

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.