Quality Engineer

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

Working pattern:

Full-time, Monday to Friday, 09:00–17:00

About the role

Contamac manufacture polymers for contact and intraocular lens materials, including materials used in cataract surgery, and are based in Saffron Walden. They are recruiting a Quality Engineer to join the Quality Assurance team, helping ensure the business and its subsidiaries meet regulatory, compliance and strategic objectives.

This role would suit a proactive, adaptable team player with strong communication skills, a positive problem-solving approach and the ability to work collaboratively across the business.

What you'll be doing

• Administer and improve the Quality Management System in line with business needs, notified body requirements and relevant international and European standards
• Support QA activities across the business, including technical files, deviations, root cause investigations, process improvements, product information and procedures
• Work with Operations to improve process controls, reduce scrap, support continuous improvement projects and maintain accurate process maps
• Conduct equipment qualifications and process validation, including protocol creation
• Contribute to risk assessments, CAPAs, deviations and periodic reviews
• Lead root cause investigations
• Perform internal audits to ISO 9001 and ISO 13485, including audit planning, non-conformance reporting, corrective action review and effectiveness checks
• Raise and track customer complaints, coordinate investigations, identify actions and monitor effectiveness
• Manage site equipment calibration activities, including SOPs, records, approvals, registers and third-party contractors
• Support customer, supplier and regulatory audits, covering ISO 13485, FDA and other applicable standards
• Develop and maintain relevant areas of the QMS to ensure continued compliance, best practice and business relevance
• Analyse QA, production and R&D data and present findings
• Write, review and amend SOPs and technical documentation
• Work collaboratively across the organisation to improve product and process quality, supporting other QA projects and investigations as required

What you'll bring

• 2+ years' experience in a highly technical manufacturing environment
• Experience with equipment qualification, process validation and protocol creation
• Strong technical written and spoken English
• Ability to influence, build relationships and support efficient cross-functional processes
• Clear communicator with good Microsoft Word and Excel skills
• Internal and/or external auditing experience
• Understanding of ISO 9001, ISO 13485 and/or GxP
• BSc or equivalent in a relevant science or engineering subject

You’ll also be a confident decision-maker with excellent attention to detail, self-motivated, resilient and flexible, with a can-do approach to your work.

What's on offer

• 5% company pension contribution
• Death in Service life assurance (4x salary)