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    • This role will lead customer quality management, supplier quality improvement, internal and external audit programmes, complex quality investigations,…
    • Act as quality advisor and subject matter expert across the Quality Unit and wider organization, providing guidance on complex quality matters.
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    • Additional certifications in quality management or medical device compliance.
    • Experience with Class III medical device validation, testing or quality assurance.
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    • Domain: Class III medical device · Validation and quality assurance.
    • Experience with system validation, testing or quality assurance in a medical device or…
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    • Domain: Class III medical device · ISO 13485 · IEC 62304.
    • Working knowledge of ISO 13485, IEC 62304 and Class III medical device validation.
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    • Domain: Class III medical device · validation and compliance.
    • Demonstrated experience with ISO 13485 and IEC 62304 in a medical device or comparable regulated…
    • Attend and contribute to internal meetings (e.g. production, quality and management review meetings) to report on inspection activity, KPIs, audit status and…
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    • Professional development in regulated medical device environments.
    • 2–5 years' experience in medical device validation, quality assurance or a related regulated…
    • Knowledge of FDA QMSR requirements and medical device regulatory expectations.
    • Experience operating within an ISO 13485-certified medical device environment.
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    • Working knowledge of ISO 13485 (medical device quality management) and IEC 62304 (medical device software lifecycle).
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    • Experience in system validation, testing or quality assurance within a medical device or regulated environment.
    • Strong analytical and problem-solving skills.
    • Monitor product quality throughout the casting process, supporting root cause analysis and ensuring products met customer specifications and quality…
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    • System Validation Engineer opportunities in medical device development typically sit within quality-focused teams delivering Class III medical devices under ISO…
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    • Developing and maintaining regulatory strategy for medical device portfolios.
    • Exposure to cutting-edge medical device development and regulatory pathways.
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    • Proven experience in regulatory affairs or medical device compliance.
    • Domain: Class III medical device · regulatory and compliance affairs.

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Job Post Details

Deep Sea Electronics Ltd logo

Senior Quality Engineer - job post

Deep Sea Electronics Ltd
3.3 out of 5 stars
United Kingdom
£30,094.77 - £50,159.22 a year

Job details

Pay

  • £30,094.77 - £50,159.22 a year

Location

United Kingdom

Benefits

Pulled from the full job description

  • Sick pay
  • Life insurance
  • Free parking
  • Company pension
  • Private medical insurance
  • Company events
  • Enhanced maternity leave

Full job description

Senior Quality Engineer

Deep Sea Electronics is a global leader in the design and manufacture of generator controllers, automatic transfer switch controllers, battery chargers, and vehicle and off-highway control systems. With over 200 employees across four continents, we supply our products to customers in more than 150 countries, both directly from our UK head office and through a well-established international distributor network.

The Senior Quality Engineer will provide technical leadership and strategic direction for quality activities across the business, ensuring robust standards, effective processes and a strong culture of continuous improvement. This role will lead customer quality management, supplier quality improvement, internal and external audit programmes, complex quality investigations, continuous improvement initiatives and compliance activities. Acting as the primary escalation point for significant quality matters, the Senior Quality Engineer will also provide mentoring, technical guidance and support to quality and operational teams.

Key Duties & Responsibilities:

Quality Leadership

  • Provide technical leadership for quality-related activities across the business
  • Act as the lead investigator for significant quality issues and customer complaints
  • Drive a culture of continuous improvement throughout the organisation
  • Mentor and coach Quality Engineers and operational teams

Customer Quality Management

  • Act as the primary quality contact for key customers
  • Lead customer complaint investigations and corrective actions
  • Coordinate customer quality audits and responses
  • Present quality performance data and improvement plans to customers where required

Supplier Quality Management

  • Develop supplier quality improvement strategies
  • Conduct supplier quality reviews and performance assessments
  • Lead supplier corrective action activities
  • Support supplier approval and development processes

Quality Systems & Compliance

  • Maintain and continuously improve the Quality Management System
  • Lead internal audit programmes
  • Coordinate external certification audits
  • Ensure compliance with ISO9001 and applicable regulatory requirements
  • Manage quality system documentation and process effectiveness reviews

Continuous Improvement

  • Lead cross-functional improvement projects
  • Facilitate root cause analysis using structured quality tools
  • Develop corrective and preventive action programmes
  • Analyse quality performance trends and recommend improvement activities

Product & Process Quality

  • Support New Product Introduction activities
  • Review quality risks associated with new products and suppliers
  • Lead PFMEA and Control Plan reviews
  • Support process capability and quality planning activities

Reporting & Management Information

  • Produce monthly quality performance reports
  • Analyse KPI trends and identify improvement opportunities
  • Report significant quality risks and opportunities to senior management

Requirements:

  • Advanced ISO9001 Quality Management System knowledge
  • Manufacturing quality systems experience
  • Root cause analysis and problem-solving methodologies
  • Supplier quality management
  • Customer quality management
  • Audit planning and execution
  • Leadership and influencing skills
  • Excellent communication skills
  • Advanced problem-solving capability
  • Ability to lead cross-functional teams
  • Data analysis and reporting skills
  • Strong organisational and planning capability
  • Significant experience within a manufacturing quality environment
  • Experience leading quality improvement projects
  • Experience managing customer and supplier quality issues
  • Internal and external audit leadership experience
  • Experience implementing corrective action programmes
  • HNC/HND/Degree in Engineering, Manufacturing or Quality-related discipline
  • Lead Auditor qualification or equivalent audit experience

Benefits:

  • 25 days holiday + Bank Holidays
  • New flexible holiday scheme
  • Bupa Healthcare package
  • Life Insurance
  • Enhanced Maternity/Paternity pay
  • 5% Pension contributions
  • Companywide performance based annual bonus scheme

Pay: £30,094.77-£50,159.22 per year

Benefits:

  • Company events
  • Company pension
  • Enhanced maternity leave
  • Enhanced paternity leave
  • Free parking
  • Life insurance
  • On-site parking
  • Sick pay

Application question(s):

  • Do you have an HNC/HND/Degree in Engineering, Manufacturing or a Quality-related discipline?
  • Do you have experience in ISO9001?
  • Are you comfortable working in an onsite setting?

Work authorisation:

  • United Kingdom (preferred)

Work Location: In person

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