Senior Quality Engineer, GET STAFFED ONLINE RECRUITMENT LIMITED

About the role

The Senior Quality Engineer will drive quality improvements through meticulous quality planning. They will oversee quality oversight of contract manufacturers, packers, and suppliers, ensuring performance, compliance, and continuous improvement.

Responsibilities

• Drive quality improvements through meticulous quality planning.
• Drive quality oversight of contract manufacturers, packers, and suppliers, ensuring performance, compliance, and continuous improvement.
• Support and oversee new product introduction and equipment transfer into manufacturing environments through validation and verification projects.
• Monitor performance through KPIs and coordinate the effective and timely resolution of any NC or CAPA.
• Work within an In-Vitro Diagnostic Quality Management System (QMS) and comply with ISO 13485, Council Directive 98/79/EC, In-Vitro Diagnostic Medical Device Regulation 2017/746, US FDA 21 CFR Part 820 and other worldwide regulatory and compliance standards.

Requirements

• Experience of working within a quality and compliance function, ideally within a medical device environment.
• Working knowledge of ISO 13485:2016 and US FDA 21 CFR Part 820.
• A passion for quality and excellent communication skills with the ability to build effective working relationships.
• Desirable working knowledge of EU IVD Directive 98/79/EC or EU MDD Directive 93/42/EEC, Medical Device Regulation 2017/745 or In Vitro Diagnostic Regulation 2017/746 and Medical Device Single Audit Program (MDSAP).
• Experience of being an internal or external auditor.

Qualifications

The ideal candidate will have a degree in a relevant field such as Engineering, Chemistry, or a related discipline, with a minimum of 5 years’ experience in a quality and compliance role within a medical device environment.

Skills

• Strong understanding of quality management systems and regulatory requirements.
• Excellent problem-solving and decision-making skills.
• Ability to work independently and as part of a team.
• Strong communication and interpersonal skills.
• Proficiency in Microsoft Office Suite.

Benefits

• Hybrid working.
• 25 days paid annual leave plus bank holidays (pro-rata).
• Company pension scheme including competitive employer’s contribution.
• Private Medical Insurance package with additional medical cash plan scheme.
• Enhanced maternity and paternity pay.
• Company supported employee Health and Wellbeing programme.
• Life assurance.
• Free electrical car charging points.
• Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London (road and rail).

Pay

Salary: £45,000 – £50,000 per annum DOE plus benefits.

Schedule

Full-Time, Permanent.