Quality Control Supervisor

Plans and supervises all reprocessing activities within the Quality Control department, concerned with the development, application, and maintenance of quality standards of manufacturing processes, raw materials, and finished products. Strictly follows and enforces established procedures and policies needed to meet the demands of Quality in a regulated medical device company.

Essential Duties and Responsibilities:

· Ensures the activities of the department remain in compliance with quality system and regulatory requirements.

· Oversees the daily quality control needs including: setting staff tasks, staffing levels, ensuring training requirements, productivity requirements, Key Performance Indicators (KPIs), hours worked, and approval of overtime.

· Creates/Revises, implements, and enforces Quality procedures for inspection, testing, identification, segregation, handling, and storage of reprocessed product and the raw materials/components to support such processes.

· Initiates and implements quality improvement activities as appropriate (e.g., Kaizen, Six Sigma) to raise the performance of the company's product lines.

· Supports and/or participates in company internal and external audits.

· Reports to management on quality issues, trends and losses.

· Responsible for all phases of inspections supporting production (incoming, in-process, finished goods, and post-sterilization.

· Responsible for appropriate labeling, storage and handling of product and materials throughout the manufacturing facility to prevent mix-ups.

· Responsible for ensuring Quarantine areas are orderly maintained and scrapping requests made by the corporate Materials Review Board (MRB) are fulfilled.

· Responsible for updating material status in ERP system following the completion of Quality activities.

· Ensures line clearance and material reconciliation activities are conducted as dictated by company procedures.

· Establishes and implements metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions.

· Assist with nonconforming product investigations, CAPAs, and customer complaints.

· Interfaces with supplier and customer quality representatives concerning problems with Quality and assure that effective corrective action is implemented.

· All other reasonable duties, as assigned.

Supervisory Responsibilities:

This position supervises Quality inspectors and is responsible for the performance, management, and hiring of the Quality Inspectors within the Quality department.

Education, Qualifications and Skills:

• Bachelor's Degree in Life Science is preferred or Associates degree with a minimum of 2 to 5 years Quality experience in the Medical Device industry; or equivalent combination of education and experience
• 1 to 2 years of Supervisory experience is strongly desired
• Experience with 21CFR820, Quality Systems Regulation and ISO 13495 strongly desired.
• Must demonstrate a high level of attention to detail in completion of tasks and cross-referencing of information in several locations.
• Must demonstrate the ability to multi-task and prioritize in a fast-paced environment, and possess flexibility when juggling numerous projects simultaneously.
• Must be proficient in Microsoft Word and other applications (Excel, PowerPoint, Adobe Acrobat, and Visio).
• Experience with J.D. Edwards ERP software use a plus.

· Must grasp instructions and information rapidly and apply them with little supervision self-motivated, self-starter.

· Knowledge and experience with labeling standards and practices is desirable.

· Strong verbal, written, organizational, time management and interpersonal skills.