Process Validation Engineer

Job Title

Job Description

The STET Quality & Process Engineer is responsible for verification / validation via the APQP-PSW process on supplier related projects. They ensure compliance to regulatory requirements and/or procedures for regulated products/processes. They will also mine CoNQ data (QN, Warranty, Scrap, Obso) to identify opportunities for improvements and then execute on those opportunities.

• Lead technical capability assessment, technology reviews and sourcing board files.

• Lead LRP and APQP Level 4, Process Validation. Drive APQP plan development, execution, monitoring and control

• Strong Understanding in Cp, Cpk and MSA.

• Deeper understanding of design within individual technical field- Plastics, PCBA, etc to drive DFMAT at suppliers.

• Lead and challenge Critical to Quality characteristics flow down to Suppliers and communicate feedback to R&D.

• Lead Analysis of defects for deciding if supplier caused and then notified for NCRs and IIA.

• Lead problem solving for SQNs, SCAR and Quality Improvement plan.

• Lead, own SICRs at site levels, and manage SICRs priorities with stakeholders.

• SME, can be a trainer. Able to demonstrate and solve complex problems using problem solving tools. Strong control over DFMEA to PFMEA linkage and process controls.

• Lead Supplier improvement and communicate the challenges and resolutions to stakeholders.

• Lead factory support per site for supplier related issues.

KEY PERFORMANCE INDICATORS

• Supplier Product Quality targets met at launch – NPI (PDLM)/MLD projects.

• Meet the requirement for Process Validation and PSW Deliverables on time to target milestones.

• Execute SICRs in timely manner to avoid any operational line down.

REQUIRED COMPETENCIES

• Stakeholder Management

• Effective Communication

• Collaboration/Teamwork

• Conflict resolution and negotiation

• Hands on Design and technical experience.

• Project Management

• Process Validation and Verification

• ISO 13485/9001 and FDA requirement

• Problem Solving skills through 6 sigma/Leon/Other strategic approach.

• Knowledge of Statistical methods and analysis. Experience with Quality tools (MSA, Process Capability and SPC).

Education & Training –

• Bachelor’s or master's degree in engineering (Mechanical/ Electronics/ Electrical)

Experience & Background

• Minimum of 10 years of related engineering experience (medical device or regulated industry preferred).

• Wide-ranging experience within an engineering function.

• Well versed in Quality Engineering and Continuous Improvement techniques.

• Direct working relationships with suppliers

• Participated in several NPIs from start to finish.

• Direct shop-floor production engineering sustaining experience

• Experience in QMS ISO-13485, IEC 60601-1

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

Indicate if this role is an office/field/onsite role.

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.