Contamac manufacture polymers for contact and intraocular lenses (used in cataract surgery) and are based in Saffron Walden.
We are recruiting for a Quality Engineer, who will work as part of the Quality Assurance Team to ensure that Contamac and our subsidiaries meet regulatory, compliance and strategic targets.
Whilst we value your experience, what is more important to us is your personality, adaptability and team player spirit. We are looking for an individual with role model ability, ready to roll up their sleeves and do what is needed to give our company, customers and suppliers, the best service with a positive problem-solving mentality.
Knowledge & Experience
Essential
- Minimum of 2-3 years in a highly technical manufacturing environment.
- Ability to conduct equipment qualifications, software, and process validation, including protocol creation.
- Excellent written and spoken English (technical) language.
- Ability to influence other departments, by suggesting, implementing and tracking more efficient processes.
- Build strong relationships with all departments to ensure continued and successful integration of QA activities.
- A clear and engaging communicator.
- Good level of computer literacy, familiar with Microsoft Word and Excel.
Advantageous
- Internal and/or external auditing experience.
- Lean Six Sigma Qualification
- Understanding of ISO9001, ISO13485 and GxP.
- BSc in a relevant science or engineering subject
Role Function
To administer and improve the QMS in accordance with company needs and the requirements set out by the company’s notified body and the provisions of the relevant international and European standards.
- Support the Quality Assurance functions of R&D and Operations
o compiling project and product technical files.
o preparing, reviewing and approving deviations and associated actions.
o ensure activities are aligned to the requirements of the QMS.
o perform root cause investigations.
o prepare, review and amend project technical files.
o investigate opportunities for process improvement and control.
o prepare, review and amend product information.
o review and maintain relevant procedures.
o support to ensure activities are aligned to the QMS.
- Work with operations to improve operational processes:
o develop, review and amend operational process controls
o reducing scrap across the business
o initiating continuous improvement projects
o develop, review and amend process maps to ensure they are accurate.
o plan, test, document and review associated actions
- Perform internal audits to ISO 9001 / ISO 13485, including:
o follow and maintain the audit plan.
o raise and document non-conformances
o review and approve corrective actions.
o identify gaps and facilitate improvements.
o verify the effectiveness of corrective actions
- Raise and track customer complaints including:
o work with relevant departments to undertake investigations
o performing root cause investigations
o identify appropriate actions and track their effectiveness
- Manage the equipment calibrations on site, internal and external
o develop and update associated SOPs
o measure and record testing, where appropriate
o review and approve calibrations, by technicians and/or third parties
o maintain the equipment calibration register
o co-ordinate all equipment calibrations, internal and external
o manage third parties or external contractors to perform calibrations
- Support discussions with customers and regulators, relating to:
o ISO 13485 / FDA and other national regulatory standards
o Develop and maintain parts of the Quality Management System; ensuring:
o they remain relevant and appropriate to the business they reflect best
practice
o they are compliant with all applicable quality and regulatory requirements
- Support supplier, customer and regulatory audits.
- Contribute to risk assessment activities.
o participate in new risk assessments
o perform periodic reviews of existing assessments with departments
o update risk assessments following CAPAs and deviations
- Perform statistical analysis of QA, production and R&D data and present the findings.
- Writing, reviewing and amending SOPs and other technical documentation.
- Work openly and effectively with all levels of the organisation, promoting a team approach and improving the quality of Contamac products and processes.
- Support the QA department with any other projects and investigations required as required.
Person Specification
- Well presented, professional individual with a can-do, positive attitude that indulges in team success.
- Self-motivated, resilient, flexible and adaptable with exceptional attention to detail.
- Confident and flexible in the way you think, making decisions efficiently and handling change, to ensure everything we do is right for our business and commercial partners.
- Excellent verbal and written communication skills
- Team player
- Attention to detail
- Self-Starter
Benefits
- Salary Range: £37,000.00 - £40,000 DOE
- Hours: 09:00-17:00 Monday to Friday
- Holidays: 25 days + 8 bank holidays
- Pension: 5% company contribution
- DIS: Death in Service Life Assurance = 4 x salary
- Parking: Free, onsite
- Company Social Events
- Electric Vehicle Scheme
- Cycle to Work Scheme
Job Types: Permanent, Full-time
Pay: £37,000.00-£40,000.00 per year
Benefits:
- Company events
- Company pension
- Cycle to work scheme
- Life insurance
- On-site parking
Application question(s):
- Are you able to commute daily to our Saffron Walden, CB11 3AU site?
Experience:
- validation : 2 years (preferred)
- ISO 9001 and / or ISO 13485: 2 years (preferred)
Work authorisation:
- United Kingdom (required)
Work Location: In person
