Quality Engineer Medical

Carolyn Woods

Quality Engineer

Waupaca, WI *****

************@*******.*** - 715-***-****

Seeking Quality Engineering opportunity with ISO 9001 company Willing to relocate: Anywhere

Authorized to work in the US for any employer

WORK EXPERIENCE

Quality Engineer

Bemis Healthcare Packaging - New London, WI - 2012 to July 2015 Responsibilities

Employed with an ISO 13485:2003 certified facility which produces flexible packaging for medical and pharmaceutical customers. During this time, I was responsible for the following tasks:

* Acted as the backup for Quality Manager. Duties included supervising five employees, customer audits, attending supervisor meetings, making quality decisions, document approvals, and successfully preparing the plant for ISO re-certification audit.

* Managed Hold Tickets and Nonconformance system which included facilitating daily meetings.

* Maintained Complaint system. Created spreadsheet and flow system keeping track of each complaint's status. Facilitated daily Management Review Board Meeting to discuss complaints.

* Investigated Root Causes and developed Corrective Actions (CAPAs) for customer complaints and non- conformances. Detailed investigations required a command of SAP functions (Enterprise Resource Planning system), batch analysis, 5-Why and fishbone analysis, ISO documentation, and knowledge of production processes of coating/lamination, blown film, and rewinding/slitting.

* Created monthly quality department reports & key measure metrics. Data analysis tools include Microsoft Excel pivot tables, Minitab, and Statistical Analysis..

* Worked directly with medical and pharmaceutical customers to resolve quality issues.

* Managed ISO 13485:2003 document system. Acted as Key Area Leader (KAL) for our facility, responsible for all ISO Documentation and backup ISO representative.

* Trained quality department employees at other Bemis facilities.

* World Class Operations Management (WCOM) Leader

* ISO 13485:2003 Internal Auditor and participated in all customer audits.

* Active member of both Quality Observation Audit Team and Safety Audit team.

* Responsible for performing instrument calibrations of lab equipment. Quality Analyst

Bemis Healthcare Packaging - New London, WI - 2005 to 2012 Quality Specialist

Bemis Healthcare Packaging - New London, WI - 1994 to 2005 EDUCATION

Bachelor of Science in Broad Field Science / Physics minor University of Wisconsin - Stevens Point, WI

Associate in Pulp and Paper Technology

Fox Valley Technical College - Appleton, WI

LINKS

https://www.linkedin.com/in/carolynwoods1

Contact this candidate