Senior Quality Engineer – PPAP

European Tech Recruit; Skåne län; On-site; SEK 700,000 - 900,000; Full time

Benefits offered by this job

€2,000 referral incentive

Job summary

European Tech Recruit is seeking an experienced Senior Quality Engineer to join a major engineering programme in Sweden. The role focuses on PPAP remediation and supplier quality within a highly regulated manufacturing environment.

You will assess supplier qualification evidence, identify gaps, and develop robust risk-based PPAP packages while collaborating with Supplier Quality, Engineering, Manufacturing and Regulatory teams to drive remediation and approvals.

Qualifications

• Experience with PPAP and risk-based documentation.
• Knowledge of PFMEA and risk management.
• Process validation experience including IQ/OQ/PQ.
• Familiarity with MSA and process capability.
• Supplier Quality Management experience.
• CAPA and Change Control knowledge.
• Experience in a regulated manufacturing environment.

Responsibilities

• Assess existing PPAP and supplier qualification documentation.
• Perform gap assessments across legacy components and suppliers.
• Develop PPAP packages based on component and supplier risk.
• Review historical quality, validation and supplier performance data.
• Support CQA and component risk assessments.
• Identify missing validation and manufacturing controls.
• Work directly with suppliers to obtain missing documentation.
• Develop supplier remediation plans and drive closure.
• Support PPAP planning, submission, review and approval.
• Provide project status, metrics and remediation reporting.

Skills

PPAP

PFMEA

MSA

IQ/OQ/PQ

CAPA & Change Control

Supplier Quality

Regulated Manufacturing

Process Validation

First Article Inspection

Measurement Systems Analysis

Education

Bachelor's degree in Engineering/Quality

Job description

European Tech Recruit is currently looking for an experienced Senior Quality Engineer to join a major engineering programme in Sweden.

This is a long-term contract opportunity focused on PPAP remediation and Supplier Quality, supporting legacy purchased components within a highly regulated manufacturing environment.

We are looking for someone who can hit the ground running, assess existing supplier qualification evidence, identify documentation and validation gaps, and develop robust risk-based PPAP packages.

You will work cross-functionally with Supplier Quality, Engineering, Manufacturing and Regulatory teams, with responsibilities include:

• Assess existing PPAP and supplier qualification documentation
• Perform gap assessments across legacy components and suppliers
• Develop reduced, partial and full PPAP packages based on component and supplier risk
• Review historical quality, validation and supplier performance data
• Support Critical Quality Attribute (CQA) and component risk assessments
• Identify missing or inadequate process validations and manufacturing controls
• Work directly with suppliers to obtain missing documentation and objective evidence
• Develop supplier remediation plans and drive actions through to closure
• Support PPAP planning, submission, review and approval activities
• Provide project status, metrics and remediation reporting

PPAP Documentation

Strong hands-on experience developing and/or reviewing:

• PPAP documentation
• PFMEA
• Control Plans
• Process Flow Diagrams
• IQ/OQ/PQ Process Validation
• Measurement System Analysis (MSA)
• Process Capability Studies
• First Article Inspection (FAI)
• Dimensional Inspection Reports
• Material Certifications
• Engineering Drawings & Design Records
• CAPA & Change Control

What We're Looking For

• Bachelor's degree in Engineering, Quality, Life Sciences or a related discipline
• Minimum 5 years' experience within Supplier Quality, Manufacturing Quality, Quality Engineering or Medical Device Quality
• Strong knowledge of PFMEA and risk management
• Process Validation experience – IQ/OQ/PQ
• Strong understanding of MSA and process capability
• Supplier Quality Management experience
• CAPA and Change Control knowledge
• Comfortable working directly with suppliers and cross-functional engineering teams
• Experience within a regulated manufacturing environment

Medical Device experience would be particularly attractive.

€2,000 REFERRAL INCENTIVE for any successful placement.

Candidates must hold a European passport or have the existing right to work in Europe.