Inspector, Receiving Goods - Quality Control - PM Shift

JenaValve is a global medical device company focused on developing and manufacturing innovative Transcatheter Aortic Valve Replacement (TAVR) systems for the treatment of patients with severe aortic regurgitation and aortic stenosis.

Our mission is to raise awareness of aortic regurgitation and transform treatment options for patients living with this condition.

Our Leeds manufacturing facility produces the proprietary porcine pericardial tissue valves used within the JenaValve TAVR System.

Joining JenaValve means becoming part of a team that is dedicated to delivering high-quality medical devices and supporting advancements in patient care across the world.

We are seeking two detail-oriented and quality-focused Receiving Goods Inspectors to support incoming inspection, First Article Inspection (FAI), and statistical sampling activities within our Quality Control team. This role is responsible for ensuring that incoming materials, components and finished goods meet defined specifications and regulatory requirements before being released for use in manufacturing.

Working closely with Supply Chain, Manufacturing and Quality teams, you will play a key role in maintaining material traceability, supporting final product release activities, reviewing documentation and labels, and ensuring compliance with ISO 13485, 21 CFR Part 820 and internal quality requirements. This is an excellent opportunity for an individual with inspection experience who enjoys working in a highly regulated medical device environment.

These roles will work the PM shift: 2.00pm to 10.00pm Monday to Friday

• Perform dimensional, visual and functional inspections of incoming materials, components and first article parts against drawings, specifications and requirements.
• Complete and maintain First Article Inspection (FAI) reports and related documentation.
• Apply approved AQL and statistical sampling plans to determine sample sizes and acceptance criteria.
• Inspect incoming materials and record inspection results and disposition decisions within the quality system.
• Support final product release activities and review completed documentation for accuracy and completeness.
• Review and verify labels for incoming materials, work-in-progress and finished goods.

• Support goods receiving activities in accordance with approved procedures.
• Collaborate with Supply Chain and Quality teams to ensure full material traceability.
• Maintain accurate inventory, stock records and materials movement documentation.
• Ensure accurate transactional recording of material movements using approved systems and controlled documents.
• Support warehousing activities and help maintain organised and compliant storage environments.
• Use appropriate handling methods to ensure safe movement and storage of materials and finished products.

• Adhere to all aspects of the Quality Management System during daily activities.
• Participate in audits, quality reviews and internal audit preparation activities.
• Support root cause investigations and corrective action activities.
• Identify opportunities to improve inspection processes and quality performance.
• Maintain accurate records in compliance with regulatory and company requirements.
• Support additional quality-related projects and activities as assigned.

• Completion of a recognised Engineering Apprenticeship, Level 3 Advanced Manufacturing/Engineering Apprenticeship, or equivalent NVQ/BTEC technical qualification; or
• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Materials Engineering or a related engineering discipline.
• Minimum of 3-5 years' experience in a Class III medical device manufacturing environment or other highly regulated manufacturing industry.
• Experience with receiving inspection, quality inspection or materials control activities.
• Experience using electronic document management systems is desirable.

• Strong attention to detail and commitment to quality.
• Ability to work independently while following detailed procedures and instructions.
• Excellent organisational skills with the ability to manage multiple priorities.
• Strong verbal and written communication skills.
• Good working knowledge of Microsoft Office applications, including Excel and Word.
• Ability to work effectively with cross-functional teams.
• Experience reading and interpreting engineering drawings, specifications and GD&T requirements.
• Knowledge of First Article Inspection (FAI) requirements and documentation practices.
• Familiarity with AQL and statistical sampling methodologies.
• Experience using inspection equipment such as calipers, micrometers, height gauges and related metrology tools.
• Understanding of calibration and gauge control requirements.
• Working knowledge of ISO 13485 and 21 CFR Part 820 requirements relating to incoming inspection and material control.

• Work within a controlled office and cleanroom environment.
• Wear appropriate cleanroom gowning and personal protective equipment (PPE) as required.
• Follow strict contamination control, quality and safety procedures at all times.
• Support operations within a highly regulated Class III medical device manufacturing environment

Salary: Subject to Experience

Plus 15% PM Shift Premium

Benefits:

• Company pension
• Free parking
• AXA Private medical insurance
• Employee Referral program
• Company sick pay
• 28 days holiday plus public holidays
• Discretionary corporate bonus