Design Quality Engineering Manager

Job Title
Design Quality Engineering Manager

Job Description

Job title:
Manager Design Quality Assurance Engineering
Your role:
Supports product development programs (new and sustaining) and leads the Design Quality Assurance local and global teams by providing regular coaching and mentoring to ensure compliance. Leads proactive design assurance activities facilitating the development and release of high quality products. Ensures standard and process compliance. Provide guidance and support during investigation and resolution of product quality or compliance issues. Emphasis placed on knowledge of standards, regulations, investigative/root cause processes, and procedures supporting compliance to industry, product quality standards and requirements. Provide technical expertise in the area of design assurance to Engineering, Operations, Customer Service, Field Service personnel and other business partners. Work with cross functional global and local teams such as: Operations, R&D, Service on root cause analysis and establishing of corrective and preventive actions. Guiding, coaching and training respective to investigative methods, risk mitigation techniques, and general product safety.

Responsibilities:
Q&R Point of Contact for the CT/AMI Innovations Segment:

• Responsible for connecting into the Q&R functions for resources and expertise.
• Empowered to be the voice for the Q&R functions (for decisions, prioritization, etc.).
• Facilitate delivery for Q&R design and development deliverables which may be performed by others within Q&R functions.
  
  

Design Quality Assurance Engineering general duties and responsibilities:

• Integral member of product development team responsible for supporting activities required to ensure quality of the design through compliance with design controls.
• Support the establishment and maintenance of design and development plans in support of quality and compliance for program and project assigned.
• Work closely with product development engineering, clinical, marketing, regulatory, and other business partners to assure appropriate quality requirements are defined for the specific device application and target patient population.
• In collaboration with product development, recommend/promote testing methodologies and approaches required to confirm that the design output meets the design input for program and projects assigned.
  
  

Participate in the review of clinical relevant test methods, design verification test plans and results, and validation test plans and results.

• Work with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to ensure device master record is complete and provide guidance to design engineering, manufacturing and product quality engineering for development of manufacturing test/evaluation methods and process validation.
• Ensure completion of the functional actions items /tasks and submission of deliverables to the document control system and report on functional group progress to team (including escalation and program review).
• Supports compliance assessments of the DHF and other program files to ensure quality and regulatory requirements are achieved and ensuring DHF completeness.
• Participates in the defects classification, defect risk analysis and investigations.
• Participates in reviews related to design, validation, defect classification and documentation as required.
• Responsible for ensuring defects, design changes and document changes are processed timely and compliantly as applicable.
• Work with a cross-functional, collaborative, team-based environment; work with multiple sites in various locations, time zones, and countries.
• Support program managers with identification and maintenance of program team interdependencies.
• Serve as a team member technical resource for problem investigations to guide root cause analysis and corrective action development.
• Work with cross functional global and local teams on root cause analysis and implementation of corrective and preventive action
• Work with cross functional global and local teams to assure product quality through the end to end product lifecycle
  
  

You're the right fit if:

• Master's degree in engineering, science, business discipline or equivalent technical certification in related field.
• 5+ years of experience in product design and development or related work experience with exposure to regulated products and experience directly or indirectly managing others.
• Expert regulatory compliance awareness including design controls and risk management in a regulated industry.
• Experience with medical device regulations, Regulatory compliance awareness such as FDA design controls CFR 820, ISO 14971, ISO 13485, IEC60601, IEC62304 and similar.
• Expert technical skills with demonstrated ability to provide solutions to a variety of technical problems of moderate scope and complexity.
• Ability to learn quickly and respond to changing priorities.
• Must have strong interpersonal communication skills as well as demonstrated ability to motivate teams.
• Ability to lead global teams.
• Technical writing and presentation skills.
• Excellent verbal and written communication skills, good team skills including project management.
• Experienced with basic PC skills (MS Word, Excel, PowerPoint, and Project).
  
  

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.