Quality Assurance Engineer

2 weeks ago

Manchester, United Kingdom Evolve Selection Ltd Full time

Are you seeking a new and exciting position with a rapidly expanding Healthcare organisation, whose culture encourages career development and progression?

Our client is in search of a motivated Quality Assurance Engineer to lead the Design Assurance activities in collaboration with cross-functional personnel.

This is a full time, remote based position with occasional travel to head office in North West England when required.

**Ideal Requirement**
- Minimum of 3 years quality/regulatory experience or relevant design/manufacturing engineering experience.
- Experience in product and process development.
- Experience working in a regulated environment.
- Ideally a minimum of 5 years quality/regulatory experience.
- ISO 13485 or FDA regulated medical device experience is desired.
- IEC62304 Software Lifecycle experience is desired.
- Ideally experience working with complex electro-mechanical systems.

**Role Responsibilities**
- Participate in core team meetings and design reviews to serve as Primary Representative of Quality and Regulatory on the product development teams.
- Review and approve all design verification and validation protocols, plans, and records.
- Ensure that design outputs meet the design inputs.
- Drive risk management file activities and updates.
- Lead the Defect Review Board for assigned products and verify acceptable resolution of design defects.
- Assist in the establishment of quality acceptance criteria and activities including but not limited to incoming, in-process and final inspection for new products.
- Ensure production equivalency is reviewed, documented, and tracked as required per verification and validation protocols.
- Participate in change control activities to ensure the Device Master Record (DMR) is maintained.
- Ensure compliance to internal QMS documentation and ISO 9001 or ISO 13485.
- Establish quality metrics for design control conformance to demonstrate the level of effectiveness of the process.

**Role Specific Competencies**
- Ability to make decisions and execute directives.
- Strongly demonstrated attention to detail.
- Self-starter, organised, analytical and decisive.
- Team oriented with strong communication skills.

**Recruitment Process**
2/3 stage process.

Interested? Please click apply, or contact Claire Handley to discuss further

Evolve is a leading recruitment and outsourcing organisation, operating within the Pharmaceutical, Healthcare, Medical Device and Life Science sectors.

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