Quality compliance specialist
Integra LifeSciences
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.
**Responsibilities:**
To perform this job successfully, an individual must be able to perform each essential duties satisfactorily as follows:
+ Work as part of the complaint investigation team within QA
+ Support complaint investigation and closure of customer complaints
+ Tracking of inter company complaints from S&R and inter company investigations
+ Management of complaint returns and timely investigation and disposition of same .
+ Management of out of box failures of spare parts and co-ordination with Service & Repair functions.
+ Management of
+ Reporting complaint data to management team
+ Review and update policies and procedures as necessary
+ Participate in CAPA teams and non-conformance investigations
+ Assist in implementing process improvement initiatives through-out the facility
+ Actively participates in product risk management activities.
+ Perform Internal audits as per schedule
+ Providing reports on quality performance and metrics as required
+ Verification of Internal audit non conformances
**Qualification:**
While a 3rd level qualification in an Engineering or Scientific discipline related discipline is preferred or a minimum of 2 years' experience working in a Quality function is acceptable, preferably in an FDA and or ISO 13485 process environment.
The successful applicant must demonstrate
+ Strong interpersonal and communication skills.
+ Excellent organization and administrative skills.
+ Highly self-motivated team player, and able to work under pressure.
+ Ability to work with Engineering and Test Departments to support resolution of product failures
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