JOB TITLE

Quality Control Supervisor

DEPARTMENT

Quality Operation

MAIN PURPOSE OF JOB AND OBJECTIVES

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Provides technical, clerical, and logistical support to the Clean Room program. Supervises inspectors in Bolton Clean Room to ensure continuous workflow and appropriate use of sampling plans and tools, as applicable. Works with other departments on the development and execution of equipment and / or test method validations. Analyzes and investigates non-conformities, and triggers CAPA escalations as needed.

KEY DUTIES

• Supervises a team of several inspectors in the Bolton Clean Room.
• Must be able to analyze trends and recommend appropriate changes to sampling plans, procedures, inspections methods, or tooling.
• Recommends modifications / improvement where advisable to minimize cost and labor.
• Coordinates and participates in audits whether that be internal or external to ensure quality compliance.
• Must be able to evaluate and implement changes for efficiency and effectiveness of inspections.
• Analyzes and investigates both in‑house and field data, reports quality problems, recommends corrective action, and follows‑up on the implementation and effectiveness of solutions.
• Assure Clean Room responsibilities are carried out in compliance with applicable quality systems (i.e.ISO13485, 21CFR820).
• Interface with Research and Development and other engineering departments to determine if process or product changes are needed based on NCR investigations.
• Requests and confirms corrections, corrective actions, and/or preventive actions from suppliers, engineers (as needed) to ensure that non-conformances are properly corrected, and recurrence is prevented.
• Updates Clean Room Quality procedures/documents as needed to ensure efficient workflow and appropriate use of equipment/tools, and sampling plans.
• Facilitates Clean Room inspector training and ensures relevant training requirements are up to date.
• Manages Clean Room non-conformance report generation, tracking and closure.

DIMENSIONS & LIMITS OF AUTHORITY

COMPANY

REQUIREMENTS

1. Must refer to relevant company handbook/policy statements detailing company procedures regarding employee conditions and benefits.
2. Authorization of purchase orders is given in Authorization of Limits produced by Finance Department

QUALITY

REQUIREMENTS

1. Ensure compliance with all quality systems regulatory requirements such as, but not limited to, ISO 13485, 21 CFR Part 820, MDSAP, MDD (93/42/EEC) and MDR (EU 2017/745)
2. Responsible for addressing issues within the QMS without undue delay as evidenced by on time completion of actions on the Single Action Tracker (SAT)

EH&S REQUIREMENTS

1. Create a safety culture and safe working environment.
2. Ensure compliance with all Environmental Health and Safety regulatory requirements.
3. Provide recourse to meet Environmental Health and Safety goals.
4. Maintain defined organization Environmental Health and Safety competencies.
5. Ensure related Risk Assessments are completed, accidents raised and action hazards.

QUALIFICATIONS & EXPERIENCE

• Excellent Written and Verbal Communication
• Understanding of quality system regulations (ISO13485, 21CFR820)
• Ability to interact with all levels within organization.
• Analytical skills for compiling and analyzing data.
• Knowledge of sampling plans
• Computer and software skills
• Ability to motivate others and improve efficiency.
• BS in Engineering or more than 5 years in the Medical Device industry with more than 5 years of experience in the quality field.
• Familiarity with management of non-conforming product.
• Familiarity with sampling plans, and failure analysis investigations.