Quality Engineer – QMS, CAPA & Audits

Midlands Arts Centre; Saffron Walden; On-site; GBP 32,000 - 46,000; Full time

Benefits offered by this job

5% company pension contribution

Death in Service life assurance (4x)

Job summary

Contamac, based in Saffron Walden, is seeking a Quality Engineer to join the Quality Assurance team. The role focuses on maintaining and improving the QMS, supporting QA activities, and driving improvements across operations and R&D.

The successful candidate will have a minimum of 2 years in a technical manufacturing environment, be adept at audits, process validation and root-cause investigations, and possess strong English communication and documentation skills.

Qualifications

• 2+ years' experience in a highly technical manufacturing environment.
• Experience with equipment qualification, process validation and protocol creation.
• Strong written and spoken English.
• Ability to influence, build relationships and support cross-functional processes.
• Clear communicator with Microsoft Word and Excel skills.
• Auditing experience (internal and/or external).
• Knowledge of ISO 9001, ISO 13485 and/or GxP.

Responsibilities

• Administer and improve the Quality Management System in line with business needs and standards.
• Support QA activities across the business, including technical files, deviations, root cause investigations, and CAPAs.
• Work with Operations to improve process controls and reduce scrap.
• Conduct equipment qualifications and process validation, including protocol creation.
• Lead root cause investigations and manage deviations and periodic reviews.
• Perform internal audits to ISO 9001 and ISO 13485 and track effectiveness of actions.
• Raise and track customer complaints and coordinate investigations.
• Manage site equipment calibration activities and ensure SOPs and records are up-to-date.
• Support customer, supplier and regulatory audits (ISO 13485, FDA, etc.).
• Develop and maintain QMS areas for continued compliance and best practice.
• Analyse QA, production and R&D data and present findings.
• Write, review and amend SOPs and technical documentation.
• Collaborate across the organisation to improve product and process quality.

Skills

QA experience

Auditing

Root cause analysis

Process validation

ISO 9001 knowledge

ISO 13485 knowledge

GxP knowledge

Communication skills

MS Word

MS Excel

Education

Bachelor's degree in science/engineering

Tools

QMS / Quality documentation tools

Job description

Contamac, based in Saffron Walden, is seeking a Quality Engineer to join the Quality Assurance team. The role focuses on maintaining and improving the QMS, supporting QA activities, and driving improvements across operations and R&D.

The successful candidate will have a minimum of 2 years in a technical manufacturing environment, be adept at audits, process validation and root-cause investigations, and possess strong English communication and documentation skills.