Senior Quality Assurance & Regulatory Affairs Engineer (UK)

COVVI; Leeds; On-site; GBP 35,000 - 45,000; Full time

Job summary

COVVI Ltd is seeking a Senior Quality Assurance and Regulatory Affairs Engineer to ensure the highest quality standards for their innovative bionic hands. The role involves compliance with regulations, documentation management, and collaboration with engineering teams. Join a dynamic team dedicated to enhancing the user experience for prosthetic users globally.

Benefits

Company pension

Cycle to work scheme

Free parking

On-site parking

Sick pay

Qualifications

• Proven experience in highly regulated environment.
• Experience with ISO 9001 and ISO 13485.

Responsibilities

• Ensure compliance with ISO 9001:2015 and ISO 13485:2016.
• Develop and maintain Technical Files for medical devices.
• Plan and deliver Regulatory registration documentation.

Skills

Communication

Regulatory Submissions

Quality Management

Education

ISO13485 Internal/Lead Auditor

4 years in Quality / Regulatory Engineer

Job description

Senior Quality Assurance & Regulatory Affairs Engineer (UK)

Senior Quality Assurance & Regulatory Affairs Engineer (UK)

5 days ago Be among the first 25 applicants

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COVVI Ltd is an innovative organisation dedicated to the design and manufacture of bionic hands for use within prosthetics and robotics fields. With a focus on user and clinician collaboration, we strive to create highly functional and accessible bionic hands that positively impact the lives of upper-body prosthetic users globally. Having recently launched our robotic hand, we seek to explore a range of use cases to aid further development. Our commitment to quality and innovation drives us to deliver award-winning products and exceptional customer experiences.

We are seeking a Senior Quality Assurance and Regulatory Affairs Engineer to join our dynamic team at COVVI Ltd. In this role, you will play a crucial part in ensuring the highest standards of quality for our groundbreaking devices. Your expertise will help us maintain our commitment to excellence and enhance the user experience for our customers.

Responsibilities

• Ensure Quality Management System (QMS) and all related documentation compliance to ISO 9001:2015 and ISO 13485:2016 including registration, maintenance, control, and improvements
• Represent the company in regulatory, quality, and scientific meetings
• Ensure that Quality System procedures are efficient, compliant, user-friendly, and comprehensively understood across the organisation. Participate in developing, improving, and writing new SOP’s
• Own and maintain quality system related documentation including supplier records and supplier evaluations, audits, purchase and manufacturing batch information.
• Develop and maintain Technical Files for medical devices compliant with the Medical Device Regulation (MDR) and UK Conformity Assessed (UKCA) standards.
• Support engineering on Design and Development project, review of design history files.
• Plan and deliver the Regulatory registration / submission documentation required to achieve global market access. Maintain compliance and timely registration for licensing and products associated with the business. Define regulatory strategies for both domestic and international markets.
• Work with the department heads for the continued development of a quality assurance culture e.g. training, working with the production team to improve quality, improvements to production processes and continuous improvement activities.
• Ensure the QA function is carried out effectively at all levels and in line with the documented operating procedures.
• Maintain and monitor quality system within the company: changes, CAPA, Non-conformities, Complaints, PMS, continuous improvement, trend analysis, etc.
• Performs visual, dimensional and functional inspection and testing according to documented policies and procedures.
• Schedule and monitor internal and external audit programme in accordance with external certification requirements. Responsible for the planning and hosting external Quality audits / inspections.
• Managing Internal Audit Schedule and perform internal audits to assess the company compliance with our QMS.
• Communicate with supply chain on discrepancies and facilitate returns and replacements, properly marking and recording rejected material.
• Segregate and protect identification and traceability of componentry and products.
• Contributes to continuous improvement projects.
• Producing quality metrics for management review and run the management review meetings,
• Leading and coordinating on calibration activities across the company
• Lead Risk Assessments, including COSHH and hazard reviews.
• Performs batch records review accordingly with compliance requirements and complete record retention process.
• Segregates and inspects finished goods samples and retain samples according to the requirements.
• Review all material test reports and documentation for approval prior to shipment. (Batch Release)
• Occasionally you may be required to perform other tasks which are not included in the above description but are within the capabilities of the individual and where necessary training will be given.

Qualifications and Experience

• Proven experience in highly regulated environment (healthcare, aerospace, defence).
• 4 years, in a Quality / Regulatory Engineer role in a comparable industry.
• Proven track record of regulatory submissions of technical files.
• ISO13485 Internal/Lead Auditor, experience with ISO 9001.
• Experience of working within a fast-moving team.
• Written and oral communication skills appropriate to dealing with technical, operational and commercial issues with customers.
• Proficiency in basic drawing/specification interpretation.

Job Type: Full-time, Permanent (Monday to Friday)

Pay: £35,000.00-£45,000.00 per year

• Company pension
• Cycle to work scheme
• Free parking
• On-site parking
• Sick pay

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

  Biotechnology

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