Quality Systems Engineer ISO 13485

4 weeks ago

London, United Kingdom Matchtech Full time

**Quality systems engineer (ISO1345)
Location: Witney, Oxfordshire, UK (hybrid working)**
**Salary**:£40,000 - £45,000 depending on experience
**The role**:
You will enable our customers to turn their concepts into reality by ensuring products are robust and fit for purpose through analysis of customers feedback, monitoring trends through Key Performance Indicators and driving improvements to ensure effective preventiveactions are implemented.
**You will require very high-level analytical skills to continuously monitor traffic, engagement and deliver insights to the teams.**
**Day to Day**:

- Implement quality vision, strategy, policies, processes, and procedures to continuously improve our operational business performance.
- Promote value added processes throughout the company and lead overall quality assurance. Drive continuous improvements ensuring the business delivers quality products and services.
- Be the quality champion by establishing effective relationships between colleagues, partners, and customers to ensure quality is an integral part of our business. Implement methodologies to ensure that our products and services exceed customer needs withinproject timescales.
- Lead effective implementation of our QMS throughout the company, including accreditation and 3rd party audits.
- Utilise KPIs and other suitable tools to measure, analyse and drive continuous improvement to help ensure the overall business objectives are achieved.
- Maintain Quality System and regulatory compliance, including continual review and implementation of changes to ensure compliance by leading internal audit programs.
- Liaise with external regulatory and customer auditors, leading and managing audit teams as required to ensure compliance.
- Collate, summarise, and communicate quality performance through metrics data in order to adhere to processes and prevent reoccurrence of NC related to product, process or systems.
- Liaise with cross functional teams and external stakeholders to implement an effective, documented process that defines quality requirements, best practice, and training materials to support continuous improvement initiatives.

**What's needed**:

- Experience in Quality System implementation (ISO9001, **ISO13485**, ISO14001)
- Experienced in Quality tools and methodologies such as FMEA, SPCM, 8D/CAPA, DMAIC, Six Sigma
- Understanding and interpretation of engineering specifications for development and manufacturing
- Experience in working in an environment where specifications and processes are not always predetermined.
- Ability to successfully manage complex issues whilst under time and cost pressure, coordinating cross-functional teams to deliver timely solutions.
- **Lead Auditor** (ISO9001 and/or **ISO13485**) (desirable)
- **Six Sigma Black Belt** (desirable)
- **Communication**: Excellent verbal and written skills and interacts confidently with stakeholders
- **Development**: Motivated, proactive, and organised; driven to further develop the role to increase impact
- **Problem Solving**: ability to understand trending data to drive improvement.
- **Cultural diversity**: understands and wholly embraces the value that cultural diversity brings to the workplace and society.

We are an equal opportunity employer and an open, supportive place to work. All applicants will be considered equally, regardless of race, origin, religion, gender identity, sexual orientation, age, or disability status.

**Benefits**:
Flexible work arrangements
Health Plan including dental and eye care
Life Insurance
Pension plan
Additional paid time off (over holiday allowance)
Learning and development incentives

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