Quality Systems Specialist
Coloplast has an exciting opportunity for a Quality Systems Specialist to join our Global Operations, Quality Systems team.
You will primarily be responsible for ensuring compliance to Quality Systems, such as training, change control, documentation, CAPA, internal audits, etc. This position will work with Interventional Urology - Implantable Device (IU ID) departments to provide guidance to these systems, as needed.
Major Areas of Accountability
- Assist with the administration of the Learning Management System (LMS) training database to ensure proper set up of employee profiles. Act as a backup for the other training administrator, as needed.
- Conduct general Quality System training to new employees.
- Coordinate and deliver annual Quality System training (GMP, GDP and others, as required)
- Approve and implement change requests involving item, equipment and manufacturing process changes for IU ID.
- Provide user training to change control and LMS systems, as needed.
- Ensure manufacturing travelers, instructions and forms are properly controlled for use.
- Provide training to individuals regarding document updates within Veeva, as needed.
- Assist with the administration of the Corrective and Preventive Action (CAPA) and Internal Audit (IA) processes.
- Assist in the backroom with document retrieval during external audits, as needed.
- This position may also assist the Quality Systems Compliance Manager on other duties, as assigned.
- Minimum of a Bachelor degree preferred
- Minimum 5 years experience required in medical device environment
- Microsoft Office - intermediate level required, or expert level preferred
- Internal auditor experience to 21 CFR 820 and ISO 13485 preferred
Required Knowledge, Skills and Abilities
- Knowledge of FDA and ISO 13485 medical device quality system requirements
- EU MDR and Medical Device Directive (MDD) experience preferred
- Ability to manage multiple projects simultaneously and prioritize accordingly
- Ability to work independently, analyze problems and develop solutions
- Must work well in a team atmosphere
- Proven ability to communicate at multiple levels of the organization
- Must be detail & deadline oriented
The job information contained herein will apply to the candidate successful in being hired for the position. If interested, please apply today!
Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with very private and personal medical conditions. Employing more than 10,000 people and with products available in more than 100 countries, we are one of the worlds leading medical device companies. We are constantly growing our business and always looking for new ways to move forward - we explore, learn and look for new ways of doing things. Curiosity works here.