Senior Quality Engineer

European Tech Recruit; Lunds kommun; On-site; SEK 700,000 - 900,000; Full time

Job summary

European Tech Recruit is seeking an experienced Senior Quality Engineer to support a major PPAP remediation project in a highly regulated manufacturing environment. You will assess and remediate PPAP documentation for legacy purchased components, collaborating with Supplier Quality, Engineering, Manufacturing and external suppliers.

The role focuses on identifying gaps, performing PFMEA/Control Plan updates, reviewing MSA and process validation activities (IQ/OQ/PQ), and guiding suppliers to

Qualifications

• Experience in Quality Engineering or Supplier Quality Engineering.
• Hands-on PPAP experience is essential.
• Strong knowledge of PFMEA, Control Plans, MSA and process capability.
• Experience with supplier/component qualification and remediation.
• Familiarity with process validation (IQ/OQ/PQ).
• Experience with external suppliers or contract manufacturers.

Responsibilities

• Review existing supplier and component qualification documentation.
• Identify PPAP documentation and validation gaps.
• Conduct component risk and CQA assessments.
• Determine appropriate PPAP requirements based on component risk.
• Develop and review Process Flow Diagrams, PFMEAs and Control Plans.
• Review MSA and process capability studies.
• Review FAI/dimensional reports and material certifications.
• Support IQ/OQ/PQ in validation activities.

Skills

Quality Engineering

Supplier Quality

PPAP

PFMEA

Control Plans

MSA

Job description

We are currently looking for an experienced Senior Quality Engineer to support a major PPAP remediation project within a highly regulated manufacturing environment.

The successful candidate will be responsible for assessing and remediating PPAP documentation for legacy purchased components, working closely with Supplier Quality, Engineering, Manufacturing and external suppliers.

Key Responsibilities:

• Review existing supplier and component qualification documentation
• Identify PPAP documentation and validation gaps
• Conduct component risk and Critical Quality Attribute (CQA) assessments
• Determine appropriate PPAP requirements based on component risk
• Develop and review Process Flow Diagrams, PFMEAs and Control Plans
• Review Measurement System Analysis (MSA) and process capability studies
• Review FAI/dimensional reports, material certifications and performance testing
• Support process validation activities including IQ/OQ/PQ
• Remediate missing validations, outdated specifications and inadequate controls
• Assess supplier and manufacturing process changes
• Work directly with contract manufacturers and sub-suppliers to close identified gaps
• Provide PPAP guidance and support to suppliers
• Track and report remediation progress and project metrics

Requirements:

• Strong experience in Quality Engineering or Supplier Quality Engineering
• Hands-on PPAP experience is essential
• Strong knowledge of PFMEA, Control Plans, MSA and process capability
• Experience with supplier/component qualification and remediation
• Knowledge of process validation and IQ/OQ/PQ
• Experience working with external suppliers or contract manufacturers
• Experience within medical device, pharmaceutical or another highly regulated manufacturing environment preferred