By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
At Integer, our values are embedded in everything we do.
Customer
We focus on our customers’ success
Innovation
We create better solutions
Collaboration
We create success together
Inclusion
We always interact with others respectfully
Candor
We are open and honest with one another
Integrity
We do the right things and do things right
REPORTING STRUCTURE
The Quality Systems Technician will report to Quality Supervisor.
ROLE
As Quality Systems Technician, you will actively support quality systems and compliance activities including review and maintenance of documents, records and data, including support for audit preparation and execution activities, Non-conformance reports, Corrections, Corrective & Preventive actions within area of responsibility, and continuous process improvement.
RESPONSIBILITIES & DUTIES
1. Compliance to applicable regulatory standards and current GMP procedures and practices.
2. Maintain QS documentation and records in a compliant state
3. Support / maintain the document and record control processes
4. Support and actively participate in audits (internal and external) and follow up activities.
5. Complete/Support administrative review for Complaint / Manufacturing Investigations
6. Initiate and process Engineering Change Notices for document updates
7. Actively support activities associated with the Supplier management process
8. Actively participate in the initiation and implementation of Non-conformance reports, Corrections, Corrective & Preventive actions within area of responsibility
9. Actively participate in continuous process improvement initiatives
10. Escalate potential deficiencies to ensure timely resolution
11. Collate/ trend and present Key Performance Indicators and Quality data to support communications and Management review
12. Participate in training events to continuously develop and maintain competencies
13. Respond to non-standard requests from customer needs
14. Support quality system compliance activities including review of standards and follow up to ensure satisfactory closure of identified gaps
15. Act as a Trainer for completion of responsibilities associated with Quality Systems and document control
16. Provide support for the document control activities and personnel
17. Performs other related duties as assigned by Quality leadership.
EDUCATION & EXPERIENCE
Minimum of 2 years’ experience working within the Medical Device / Pharmaceutical Industry.
Previous work experience within QS/QA/QC environment.
Knowledge of Medical device Regulatory requirements (e.g. ISO13485, FDA QSR 21CFR Part 820)
Level 7 or 8 Degree in Manufacturing / Quality Engineering / Life Sciences
Capabilities & Abilities:
18. Knowledge of and adherence to Quality systems
19. Good computer skills in usage of MS Office Suite - Microsoft word / Excel / PowerPoint
20. Proficiency with Electronic QMS systems (e.g. SharePoint, Reliance, etc)
21. Ability to work on own initiative as well as part of a team.
22. Good documentation skills with strict attention to detail
23. Logical and methodical approach to work practices and processes
24. Strong written and verbal communication skills are essential
25. Basic understanding of statistical techniques
26. Resilient to deal with challenging situations
27. Capable of influencing change
28. Highly Motivated
29. Self-aware / Optimistic / Empathetic
U.S. Applicants: EOE/AA Disability/Veteran