Quality Engineer - PPAP Remediation Consultant – Legacy Components

Job description

We are looking for a talented Senior Quality Engineer to join our company. Sigma Industry Evolution is expanding rapidly and we welcome you to join our amazing team! Apply as soon as possible!

We are seeking an experienced SeniorQuality Engineer to support the development and remediation of Production Part Approval Process (PPAP) documentation for legacy purchased components. The consultant will in conjunction whith contract manufacturer assess existing supplier qualification evidence, identify documentation and validation gaps, and establish risk-based PPAP packages that demonstrate supplier process capability, manufacturing control, and compliance with quality requirements.

The consultant will work cross-functionally with Supplier Quality, Engineering, Contract Manufacturer, Advanced Operations and Regulatory Affairs, to ensure legacy components are supported by appropriate PPAP documentation and objective evidence.

#LI-IK1 #SIE

Basic qualifications

Key Responsibilities PPAP Assessment and Remediation

• Evaluate existing supplier and component qualification documentation for legacy components.
• Support risk assessments, including Critical Quality Attribute (CQA) evaluations and special process reviews, to determine the appropriate PPAP level for individual components.
• Develop reduced, partial, or full PPAP packages based on component criticality, supplier risk, and business requirements.
• Review historical quality, process validation, and supplier performance data to support PPAP remediation activities.
• Collaborate closely with the PPAP Coordinator to support PPAP planning, submission, review, and approval activities.

PPAP Documentation Development

Develop and/or review:

• Design records and engineering drawings
• Process Flow Diagrams
• Process Failure Mode and Effects Analyses (PFMEA)
• Control Plans
• Measurement System Analysis (MSA) documentation
• First Article Inspection (FAI) and dimensional inspection reports
• Material certifications and performance test reports
• Process capability studies
• IQ/OQ/PQ validation documentation

Gap Assessment and Compliance Activities

Identify and drive resolution of:

• Missing process validations
• Incomplete or absent PPAP documentation
• Obsolete or uncontrolled specifications
• Inadequate process controls
• Missing inspection and test evidence
• Supplier changes lacking formal evaluation or approval
• Documentation inconsistencies between supplier and records

Supplier Engagement

• Collaborate directly with Contract Manufacturer and Sub-suppliers to obtain missing documentation and objective evidence.
• Facilitate supplier training and awareness regarding PPAP requirements.

Quality and Regulatory Support

• Ensure PPAP activities align with supplier quality requirements.
• Generate status updates, metrics, and remediation reports to PPAP coordination for Project review.

Deliverables

The consultant will be expected to deliver:

• Component risk assessment matrix
• Legacy component PPAP remediation strategy
• Gap assessments for targeted suppliers and components
• Complete or risk-based PPAP packages
• Supplier remediation action plans
• Validation and process control recommendations

Preferred additional skills, personal traits and experience

Required Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or related discipline.
• Minimum 5 years of experience in Supplier Quality, Manufacturing Quality, Quality Engineering, or Medical Device Quality Systems.
• Demonstrated experience developing and reviewing PPAP documentation.
• Strong knowledge of:
• PPAP methodologies
• PFMEA and risk management
• Control Plans
• Process Validation (IQ/OQ/PQ)
• MSA and capability studies
• Supplier Quality Management
• CAPA and Change Control processes

More information

För mer information kontakta

Ivan Kertan,
+46 761287807
Ivan.Kertan@sigma.se