Be accountable for development and delivery of quality and process strategy in the business.
It ensures compliance to regulatory requirements and procedures for regulated products/processes including high quality performance of suppliers. Implements STET Quality / Process Engineering, Purchasing Controls and Supplier Quality processes related to the development / sustainment, procurement and continuous improvement of manufacturing materials, components, software, sub-assemblies, contract manufactured finished devices/products or services, and their introduction into Philips supply chain. Ensure compliance to regulatory requirements and/or procedures for regulated products/processes.
Ensure raw material and component specs and drawings are translated to supplier quality requirements, qualify suppliers, assess metrics to include QN reduction.
Ensure supplier products meet quality specifications, and audit suppliers critical to quality processes.
Ensure that verification / validation as part of product realization process is completed in accordance with PDLM-MLD & APQP-PSW processes to ensure the sustained quality and compliance of supplied raw materials and components.
Ensure correction and prevention activities of suppliers are timely and effective.
In this role you are responsible for
Work with STET Program Mgrs. / sustaining BG/ BU SQE on all MLD/LCM projects to lead APQP-PSW deliverables to achieve Philips STET organization Business Goal.
Work with Manufacturing Quality/SQE/ME etc. to lead or be a part of a team member for QN reduction projects
Duties and responsibilities include:
61 Provide Quality / Process Engineering leadership and vision to enable the STET organization’s short- and long-term project objectives
61 Develop and deploy Quality / Process Engineering quality strategy in line with STET supply management and business strategy
61 Deploy, set, assesses, and decides (veto) on the quality aspects in support of the STET project Supplier Selection process
61 Ensures the assigned STET project suppliers meet the Philips sustainability requirements
61 Execute PSW and Complete Process Validation with scheduled project time.
61 Support Business Remediation program.
61 Ensures the timely implementation of Continuous Improvement activities in QN setting for STET project suppliers based on project business needs
61 support on-site/off-site project supplier quality development from APQP-PSW standpoint including execution support of all PSW approval stages.
61 Performing requisite supplier technical assessment and quality system audits where needed
61 of molds between suppliers to minimize time delays and cost overruns to meet TCO objectives
61 Assesses risk related to required injection molding process equipment / tooling /processes
61 Supports and participates in vendor selection, mold / materials design assessment and manufacturing processes and equipment and tooling assessment.
Requirements
61 BS or above in an engineering (ie; mechanical / electrical / industrial)
61 8+ years total industry experience with 2+ years of experience in a medical device or regulated industry in SQE role.
61 Knowledge, understanding with quality systems, quality tools and methodologies, including APQP-PPAP/PSW process Critical to Quality, FMEA, Root Cause Analysis , Pareto, 8-D, 5 Why, Audit training, skills, or willingness to learn; experience with auditing suppliers preferred.
61 Preferred Industry Experience: Automotive / Aerospace / Medical
61 Competencies and skills:
61 Execution knowledge of statistical methods, quality tools and methodologies (CtQ, SPC, APQP, FMEA, MSA/GR&R, Control Plans, SCAR, etc).
61 Strong Problem Solving skills and experience.
61 Six Sigma GB preferred.
61 Ability to work independently, think analytically, and apply methodical engineering problem solving skills required. Capable of performing root cause analysis and identifying solutions to complex manufacturing problems
61 Ability to influence others and build effective working relationships both internally and externally at various organizational levels.
61 Professional communication skills in English is a MUST, both oral and written.
61 Ability to travel up to 20+%.