Job Summary
Provides technical, clerical, and logistical support to the Quality Operations program. Supervises inspectors in Quality Control Operations Areas 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.
Job Details/Responsibilities
- Supervises a team of several inspectors in the Quality Control Operation Areas.
- 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 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 Quality procedures/documents as needed to ensure efficient workflow and appropriate use of equipment/tools, and sampling plans.
- Facilitates inspector training and ensures relevant training requirements are up to date.
- Manages non-conformance report generation, tracking and closure.
Job Responsibilities (continued)
Quality requirements:
- 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)
- 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:
- 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).
- Responsible for addressing issues within the QMS without undue delay as evidenced by on time completion of actions on the Single Action Tracker (SAT).
- Provide recourse to meet Environmental Health and Safety goals.
- Maintain defined organisation Environmental Health and Safety competencies.
- Ensure related Risk Assessments are completed, accidents raised and action hazards
Knowledge, Skills and Abilities (KSA)
- 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.
Qualifications/ Background Experiences
- 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.
