Senior Inspector, Quality Control

Description

Job Title: Senior Inspector, Quality Control

Supervisor/Manager Title: Manager, Quality Assurance

Job Description Summary: The role requires the holder to lead, co-ordinate, and undertake quality control activities related to the manufacture of the THV. To include in-process and final inspection, labelling/packaging, documentation, and environmental monitoring. The role holder will also provide routine reports and communications to provide timely updates on inspection status.

Job Responsibilities:

• To supervise quality staff engaged in QC activity, planning work activity, and facilitating Quality tasks to achieve the most efficient use of people and equipment resource.
• To plan QC activities required to maintain the throughput of THV and component level items and ensure process coverage and prioritization of QC resource across all areas of operations.
• To support the training of personnel in QC tasks. Contributing to training plan materials and development of best practices in training delivery and competence.
• To produce reports to ensure that key stakeholders are kept informed of QC testing outcomes.
• Contribute to continuous improvement efforts related to valve manufacture and inspection processes.
• Conduct routine testing on THV, to include functional, visual, and final inspection processes.
• Conduct sterilization preparation of THV and associated documentation.
• Audit tissue and THV DHR’s to ensure procedural and GDP requirements are met.
• Inspect final packaging labels to confirm they are applied correctly per standards/work instructions.
• Service requests from stakeholders relating to THV inspection data.
• Adhere to Quality System and record retention requirements.
• Comply with all site Health & Safety requirements.

Qualifications

Required Education and Experience:

• A-Levels, or equivalent and substantial relevant practical experience are required. Bachelor’s degree in Biology, Chemistry or a Biomedical related discipline is desired.
• A minimum of 3-5 years’ experience in a Quality role within the medical devices or pharmaceutical industries is a requirement.
• Must be familiar with 21CFR820 and ISO 13485 requirements, with specific focus on requirements relating to manufacturing operations.
• Experience assessing products for compliance and final release is required.
• Previous experience in a supervisory capacity is desirable.

Skills and Abilities Required for This Job:

• Confident decision maker, able to articulate and support decisions made.
• Can identify work priorities and deploy resource to ensure business needs are met.
• Must be able to work effectively and collaborate within cross functional teams.
• Must possess the ability to handle multiple tasks, with high attention to detail.
• Ability to file and organize records in a compliant, easily retrievable manner.
• Ability to read/understand design and manufacturing drawings and documents.
• Competent in publishing reports on manufacturing/inspection performance.
• An effective coach who can develop other competencies with QC tasks.
• Must be able to effectively articulate (verbally and in writing) results and conclusions.
• An advocate for change and continuous improvement.

Salary : $29