Quality Inspector -Medical Devices - Manufacturing

ZipRecruiter; England; On-site; GBP 60,000 - 80,000; Full time

Job description

Job Description

Our client, a leading Scientific Imaging Manufacturer, is looking to appoint an experienced Quality Assurance Associate / Inspector to join their team.

The Quality Assurance Associate / Inspector will be responsible for supporting in the control and management of all documentation and processes related to the Quality Management System (QMS), Environmental Management System (EMS), and Health & Safety (H&S).

As a Quality Assurance Associate / Inspector, you will play a key role in ensuring the quality and compliance of engineering processes and products. Working closely with the QSE (Quality, Safety & Environmental) Manager and other departments, you will assist in developing, implementing, and monitoring quality control systems to meet industry standards and customer specifications.

Key areas of responsibility

Goods Inwards Inspection

1. Carry out Goods Inward inspection for component parts entering the company ensuring compliance to design specification and contractual requirements.
2. This includes visual inspection, manual measurements, and programming and maintaining our OGP (Optical Gaging Product) inspection equipment.
3. Maintain accurate quality inspection records for traceability, as per the sampling plan, suggesting improvements to process where applicable.
4. Complete First Article Inspection Reports (FAIR) where required.
5. Analyse quality data to identify trends and recommend improvements to enhance product quality and reduce defects.
6. Liaise closely with the Engineering, Purchasing, and the Production teams to identify and address quality issues promptly.

Calibration

1. Ensuring all measurement equipment is maintained and calibrated in accordance with the company’s internal procedures.
2. Maintain calibration records.

QMS Support

1. Maintain, update, and organise all documentation related to the Quality Management System (QMS), Environmental Management System (EMS), and Health & Safety (H&S).
2. Support the implementation, monitoring, and improvement of processes to comply with our quality and safety standards.
3. Ensure accurate version control and accessibility of critical documents for relevant stakeholders.

Compliance and Auditing

1. Conduct and assist with internal and external audits and inspections to verify adherence to the QMS, EMS, and H&S regulations.
2. Coordinate corrective and preventive actions based upon audit findings and follow up on action implementation.

Training Coordination

1. Assist in organizing and tracking internal and external employee training, including induction of new starters, to ensure QMS standards are maintained.

Data Analysis & Reporting

1. Collate, analyse, and report on quality metrics and trends, process improvements, and document control activities to support continuous improvement initiatives.
2. Communicate with relevant departments to ensure clarity and understanding of QMS, EMS, and H&S procedures.

H&S and Environmental Management

1. Support initiatives in line with ISO 14001, coordinating our waste management and encouraging sustainability practices.
2. Co-ordinate all COSHH processes and procedures.

Customer & Supplier Quality

1. Collaborate with suppliers and customers to address quality concerns, including RMA’s, to ensure quality standards are maintained.
2. Co-ordinate final goods inspection prior to shipping.

Desired Qualifications

• A degree or equivalent qualification in engineering, quality management, or a related field – desirable.

Essential Experience

• At least 1-2 years of experience in a quality assurance or engineering support role, preferably in the engineering or manufacturing sector. Strong understanding of quality control processes, inspection techniques, and industry standards. Goods Inward inspection processing and standards.

Essential Knowledge

• Strong knowledge and understanding of international quality standards (ISO 9001 and ISO 14001). Documentation Control experience in line with ISO standards.
• Ability to support in managing Safety Data Sheets (SDS), COSHH assessments, and risk assessments. Experience with support for both internal and external audits.
• Continuous Improvement mindset.

Essential Skills and Abilities

• Read and interpret mechanical & technical drawings and documents.
• Excellent verbal and written communication skills.
• Strong Problem Solving skills.
• Excellent personal organisation.
• Dynamic, positive, enthusiastic, and possess the ability to think laterally and act through reasoned decision-making.
• Ability to work productively, efficiently, and effectively with initiative and drive under tight timescales and pressure whilst maintaining attention to detail and quality.