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Requisition ID 22974BR
Job Title Quality Control Supervisor
Division MedSurg Ops
Business Unit Sustainability Solutions
Business Functions Quality Assurance Safety
Business Sub-Functions Production Quality Assurance
Country United States
Job Description The QC Supervisor – Product Release Coordinator is required to have exceptional knowledge regarding the document review, incoming raw materials and post-sterilization processes. The QC Supervisor – PRC must also have strong leadership skills and will be responsible for ensuring that their department is running efficiently and effectively. Other areas of responsibility include coordination of product holds and release, product disposition, nonconformance investigations, and other responsibilities as assigned by the QC Manager.
DUTIES & RESPONSIBILTIES:
- Maintain a complete understanding of the process and procedures for all product lines.
- Ensure that all QC Department employees follow approved procedures.
- Work closely with QA/QC Management to ensure adequate staffing and provide maximum workflow.
- Monitor head count according to budget/capacity and strive for continuous improvements in the area.
- Respond to Management requests/inquiries in a timely manner.
- Attend all functions and meetings directly associated with departmental duties.
- Track and Trend QC System productivity and efficiency.
- Provide additional
training to employees as needed, document and submit training records appropriately.
- Troubleshoot any issues regarding Incoming Inspection documentation.
- Assists QC employees as needed.
- Ensures timely processing/release of sterilization batches.
- Directly conduct disciplinary actions, hiring, terminations, interviews, and the approval of vacations and paid days off.
- Handle employee situations in regards to time cards.
- Manage employee overtime based upon Management directives.
- Provides fair and ethical Supervision to all subordinates.
- Ensure Completeion of all projects assigned by the QC Manager.
- Work safely at all times and immediately report any unsafe conditions and/or injuries to QC Management, Facilities, and Human Resources.
- Initiate, obtain approvals, and execute (electronic and/or physical) Product Holds per procedural requirements. Maintain appropriate files and records during and after resolution of Product Holds.
- Ensure adequate back-up support is available for all product release activities.
- Ensure routing of nonconformance reports for completion from initiation to final approval/closure. Log and file nonconformance reports.
- Provide periodic reports regarding Product Holds and nonconformance data for trending, analysis, and management review purposes.
- Initiate PCO’s, ECO’s, DAR’s, and TCN’s when appropriate.
- Perform internal audits as directed.
- Perform other duties as assigned by QA/QC Management.
- Responsible for effectively giving direction and managing QC employees as directed by the approved organizational chart.
EDUCATION & EXPERIENCE:
- A Bachelor’s Degree
- Quality Inspection experience is a plus.
- Minimum one (1) year experience in a medical device preferred or similar manufacturing environment.
- Must be able to read, write and understand English.
- Must have good math skills.
- Must be reliable, hard working, and professional.
- Must have excellent attendance and punctuality.
- Must have exceptional organizational skills.
- Strong written and oral communication skills.
- Strong, working knowledge of current FDA and ISO requirements as they relate to medical device manufacturing.
- Strong interpersonal skills, with the ability to work effectively in a team. Should also be able to form and lead a team, as necessary.
- Computer experience required, including JD Edwards/One World XE.
- Proficient in Microsoft Word, Excel, Power Point, Outlook.
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