CyDen
Contract PPAP / APQP Engineer
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We are seeking an experienced Contract PPAP / APQP Engineer to join our Quality team during a period of increased project activity.
Reporting to the Head of Quality, you will play a key role in supporting the delivery of APQP and PPAP activities across multiple NPI projects. This is a hands-on role requiring an experienced quality professional who can quickly integrate into the team, work with minimal supervision and immediately contribute to active programmes.
Working closely with Engineering, Manufacturing, Supply Chain and Suppliers, you will ensure production parts, processes and documentation are completed to the required quality, regulatory and manufacturing standards to enable successful product release.
This role is focused on delivering high-quality PPAP and APQP outputs and providing additional experienced resource to support an expanding project workload.
Key Responsibilities
APQP / PPAP Delivery
- Independently complete APQP and PPAP activities across assigned NPI projects.
- Prepare and maintain PPAP documentation to support successful production release.
- Complete and review:
- Design Failure Mode and Effects Analysis (DFMEA)
- Process Failure Mode and Effects Analysis (PFMEA)
- Process Flow Diagrams
- Control Plans
- FAIR documentation
- Supporting validation documentation
- Support prototype, pilot and pre-production builds including IQ, OQ and PQ activities.
- Ensure all APQP milestones are achieved in accordance with project plans.
Supplier Quality
- Work directly with suppliers to obtain, review and approve PPAP documentation.
- Support supplier quality activities and resolve PPAP documentation issues.
- Ensure supplied components meet CyDen quality requirements and regulatory expectations.
- Support supplier audits where required.
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Quality Support
- Represent Quality during NPI project meetings.
- Support Engineering and Manufacturing teams in resolving NPI quality issues.
- Investigate quality concerns arising during development and early production.
- Review Engineering Change Notices (ECNs) to assess quality impact.
- Ensure lessons learnt from production and field performance are incorporated into new product development.
Documentation & Compliance
- Produce and maintain accurate APQP and PPAP documentation.
- Ensure all quality documentation is completed in accordance with company procedures.
- Support compliance with ISO 13485, FDA requirements and other applicable regulatory standards.
- Ensure all documentation is completed accurately and on time.
Continuous Improvement
- Support continuous improvement of APQP and PPAP processes.
- Identify opportunities to improve documentation, process efficiency and production readiness.
- Share knowledge and best practice with colleagues where appropriate.
General
- Work across multiple NPI programmes simultaneously.
- Prioritise workload to support key business deliverables.
- Carry out any other reasonable duties requested by the Head of Quality.
Key Objectives / KPIs
- Timely completion of APQP deliverables.
- Timely completion of PPAP packages.
- Successful production release of assigned NPI projects.
- Supplier PPAP approvals achieved to programme milestones.
- Reduction in NPI quality issues.
- High-quality documentation completed right first time.
- Effective collaboration with Engineering, Manufacturing and Supply Chain.
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Essential Experience & Skills
- Minimum five years' experience completing APQP and PPAP activities within a manufacturing environment.
- Demonstrable experience completing full PPAP packages independently.
- Strong working knowledge of AIAG Core Tools including:
- APQP
- PPAP
- DFMEA
- PFMEA
- Control Plans
- MSA
- SPC
- CAPA
- Experience supporting product introduction from development through to production.
- Experience working with suppliers on PPAP submissions and approvals.
- Strong understanding of manufacturing processes including injection moulding, electronics/PCB assembly and mechanical assembly.
- Experience working within regulated manufacturing environments.
- Excellent problem-solving skills.
- Strong communication and stakeholder management skills.
- Excellent attention to detail.
- Ability to manage multiple priorities.
- Able to work independently with minimal supervision.
- Able to hit the ground running in a fast-paced manufacturing environment.
Desirable Experience
- Experience within medical devices.
- Experience within automotive or aerospace manufacturing.
- Working knowledge of ISO 13485.
- FDA quality system knowledge.
- IATF 16949 experience.
- Six Sigma Green Belt or Black Belt.
- Lead Auditor qualification.
Qualifications
Essential
- Degree, HND or HNC in:
- Mechanical Engineering
- Manufacturing Engineering
- Production Engineering
- Quality Engineering
- Quality Management
- Or equivalent practical experience.
Desirable
- Six Sigma qualification.
- CQI or ASQ Quality qualification.
- Lead Auditor qualification.
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