Validation Engineer

Responsible for leading PPAP and validation activities for new medical device programs, ensuring compliance with ISO 13485, FDA 21 CFR Part 820, GMP, and applicable quality standards.

Job Requirements

• Minimum of 5 years of experience in product quality engineering, including direct experience with PPAP and validation deliverables.

• Experience in the medical device or life sciences (GxP) industry.

• Bachelor's degree in Engineering or equivalent relevant experience.

• Extensive experience developing and executing Production Part Approval Process (PPAP) packages and validation documentation.

• Experience with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

• Knowledge of ISO 13485, FDA 21 CFR Part 820, and Good Manufacturing Practices (GMP).

• Experience with quality assurance (QA), quality control (QC), and quality system audits.

• Knowledge of Advanced Product Quality Planning (APQP), including FMEA, Control Plans, Process Flowcharts, Capability Studies, and Gage R&R.

• Ability to read and interpret engineering blueprints, technical specifications, ANSI/ISO drawing standards, and Geometric Dimensioning and Tolerancing (GD&T).

• Knowledge of statistical analysis, Statistical Process Control (SPC), Measurement System Analysis (MSA), and Gage Repeatability and Reproducibility (GR&R).

• Experience with quality inspection tools, measurement equipment, and inspection methodologies.

• Technical writing experience with validation protocols, standard operating procedures (SOPs), and quality documentation.

• Proficiency in Microsoft Word, Excel, and PowerPoint.

Preferred Skills

• Graduate degree in Engineering, a technical discipline, or Management.

• Experience using Minitab for statistical analysis.

• Knowledge of Total Quality Management (TQM), Six Sigma, and Lean Manufacturing principles.

• Experience with progressive metal stamping and insert molding processes.

• Experience with Material Requirements Planning (MRP) or Enterprise Resource Planning (ERP) systems.

• Experience with Design of Experiments (DOE) and process capability analysis.

• Experience supporting medical device product development and manufacturing program launches.

Job Responsibilities

• Lead the development, execution, and completion of PPAP and validation packages for new medical device customer programs.

• Prepare Master Validation Reports and develop and execute IQ, OQ, and PQ protocols.

• Manage PPAP activities and ensure completion of all required APQP documentation and deliverables.

• Develop and maintain validation documentation, SOPs, technical specifications, and quality procedures for new programs.

• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, GMP, and applicable regulatory requirements.

• Develop and review APQP documentation, including Design of Experiments (DOE), FMEAs, Process Flowcharts, Control Plans, Capability Studies, and Gage R&R studies.

• Perform statistical analysis using SPC, MSA, GR&R, and process capability methodologies.

• Support program management activities related to new medical device product launches.

• Participate in product design and development reviews to establish quality requirements and validation deliverables.

• Represent customer quality requirements throughout product development, validation, and manufacturing processes.

• Oversee the development and entry of initial Bills of Materials (BOMs) and detailed manufacturing routings.

• Initiate and coordinate Engineering Change Orders (ECOs) and associated documentation updates.

• Serve as the primary auditee for PPAP, validation, and APQP documentation during third-party audits.

• Lead and support customer, internal, and registrar quality system audits.

• Review engineering drawings, specifications, and manufacturing processes to ensure compliance with established quality requirements.

• Support quality assurance and quality control activities, including inspection planning and process verification.

• Identify and implement quality system and manufacturing process improvements using Lean, Six Sigma, and continuous improvement methodologies.

Pay Details: $100,000.00 to $130,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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• Los Angeles County Fair Chance Ordinance for Employers
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