Quality Engineer PM Consultant

Description:

The Quality Engineer promotes and implements organizational policies & standards to ensure product quality from design transfer to warehouse and distribution, including postponement/late customization, in compliance with regulatory requirements and Philips' Business Systems/procedures.

Qualified applicants have good medical device IT systems experience along with quality planning. They will assist with the implementation of SAP but SAP experience is not a required. This knowledge will be from a quality standpoint and IT validation should also be within candidate’s skillset.

This position will:

• Ensure compliance with the Quality Management System, in accordance with Philips Policies and applicable worldwide regulations and standards.

• Facilitate development of and sustaining activities in support of core supply chain quality functions including nonconforming material management, acceptance activities, and general quality system functions for warehousing, distribution, manufacturing, and merge activities.

• Provide quality support to Integrated Warehousing and Distribution functions.

• Support and Review where applicable Process Development, Validation, and Quality Controls throughout the lifecycle of supply chain products/solutions ensuring all necessary documents/records are maintained throughout the lifecycle of the product/solution.

• Partner with Supplier Quality on processes related to the acquisition of purchased services, solutions, materials, components, sub-assemblies, and completed products and to ensure vendor assessments are completed

• Accountable for implementing and managing quality system requirements for warehouse and distribution projects. This includes leading quality planning activities.

• Responsible for leading quality assurance activities, such as:

• Responsible to ensure Supply Chain quality systems are maintained and documented.

• Participates and supports the completion of NPI and Product transfers in the supply chain locations.

• Reports on project timelines and tracking of product transfers.

• Reviews and approves quality documentation and records, and responsible for generation where applicable.

• Analyzes data for reports and validation activities as well as process improvement initiatives.

• Assists with delivery hold execution and leads some hold activities.

• Responsible for Non Conformance Management (Root Cause Analysis, Corrections, Corrective and Preventive Actions) in accordance with required timelines.

• Accountable for ensuring timely review and approval of nonconforming records for nonconforming material within the warehouse and facilitating appropriate product dispositions partnering with business where necessary.

• Responsible to meet departmental metrics.

• Drive lean initiatives, continuous improvement and complete QEKs, VSMs.

• Provide Q&R oversight on Operations projects ensuring timely completion and appropriate quality of project deliverables.

• Knowledge of Supply Chain operations related to warehouse, distribution, and manufacturing and quality system requirements.

• Frequently interacts with subordinate supervisors and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.

• Minimum of 3 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 preferred.

• Participated in several NPIs from start to finish.

• Prior experience in working in a manufacturing or warehouse related environment preferred.

• Ability to manage competing priorities in a fast-paced environment.

• Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), EU MDR, Japanese MHLW Ordinance 169, and ISO 9001.

Requirements:

• Bachelor degree in Engineering Science, or equivalent experience.

• 3, or more, years of experience in a medical device or regulated industry.

• Knowledge of Supply Chain operations related to warehouse, distribution, and manufacturing and quality system requirements.

• Frequently interacts with supervisors, managers and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.

• Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.

• Follows processes and operational policies in selecting methods and techniques for obtaining solutions

• Often must lead a cooperative effort among members of a project team.

• Strong knowledge of Design Transfer, Acceptance Activities, Production and Process Controls, and Supplier Quality Design Transfer activities.

• Excellent technical, writing and communication skills and interpersonal relationship skills including negotiating and relationship management skills.

• Identifies technical and process gaps and takes action to address them.

• Relentless focus on Product Quality as an organizational value.