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Sr. SQA Manager

Company: Philips
Location: Bothell
Posted on: January 15, 2022

Job Description:

Job TitleSr. SQA ManagerJob DescriptionEffective Wednesday, December 8, 2021, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips. Employees with a sincerely held religious belief and/or disability impacting their ability to obtain the COVID vaccine can request a reasonable accommodation.If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.But it's not just what we do, it's who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers' needs. It's what inspires us to create meaningful solutions - the kind that make a real difference - when it matters most.The world and our customers' needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That's why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.In this role, you have the opportunity to make life betterLooking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.In this role, you have the opportunity toAssure that the Quality systems at the suppliers (including contract manufacturers) and Philips HealthTech meet relevant Purchasing Controls requirements; scope of activity includes all QMS relevant Purchasing Controls processes, systems and procedures, as well as Q&R processes indirectly related to Purchasing Controls (e.g., CAPA, audit). Participate in the development and continuous improvement of suppliers' Quality Assurance processes to ensure high quality and compliance. SQA is accountable and responsible for supplier audits, external inspections/ audits of Purchasing, and training.KEY AREAS OF RESPONSIBILITIES

  • Leads KAR related assignments within BG/Markets/SVAL.
  • Shapes relevant Philips Excellence practices to identify and solve major supplier quality issues where simple analysis of Supplier Quality data is required.
  • Has a multi-disciplinary approach and knowledge of Supplier Quality principles, theories and concepts; including ASL Management, Auditing, SCAR Coordination, Performance Monitoring, APQP, and Quality Transition Plans.
  • Formulates the Supplier Quality solution by combining previous experiences and by composing newly acquired Supplier quality knowledge.
  • Leads multi-disciplinary change projects in supplier quality, managing a number of people, ensuring deliverables and milestones are met.
  • Introduces Supplier Quality methods/procedures that are new for the organization
  • Applies advanced Supplier Quality process principles to multiple tasks.
  • Take difficult complex problems to shape them and create executional plans
  • Displays full understanding of an area of specialization; resolves a wide range of issues in creative ways.
  • Has complete knowledge of company products and services.
  • Frequently interacts with suppliers/customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company.
  • Lead strategic and tactical teams, fostering a cooperative effort among members of a project team.
  • Leverages appropriate communication and stakeholder management skills to deal with different levels of cross functional people
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
  • Demonstrates good judgement in selecting methods and techniques in obtaining solutions
  • Networks with senior internal and external personnel in own areas of expertise.
  • Able to see big picture, including any impact to the value chain (customer, supplier, Philips) and ensure related stakeholders are on the same page.
  • Receives little instruction on day-to-day work, general instructions on new assignments.
  • Able to make decisions based on experience, data, and facts, as well as ensuring insight from others.
  • Impact of CoNQ> $2MYou are a part ofAs a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.To succeed in this role, you'll need a customer-first attitude and the following
    • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
    • Bachelor's Degree with 5+ years' experience in Suppler Quality Assurance.
    • APQP Awareness
    • Medical Device Awareness: ISO 13485 & FDA QSReg (21 CFR Part 820), MDSAP, CMDR, MDD, jPMD
    • Personal Care Awareness: ISO 22000/ FSSC 22000, ISO Standards 97.020, 97.030, 97.040, 97.060, 97.080, 97.170
    • REACH and RoHS Awareness
    • Good Documentation Practices
    • Good Manufacturing Practices
    • SCAR Ownership, Execution and Independent Review
    • Supplier Sustainability
    • LEAN: Including Daily Management
    • Six Sigma: Including DFMEA, Value Stream Mapping, Minitab, MSA, Cpk, SPC
    • QMS Relevance including Application and Implications: Including ISO 9001, Standards and Regulations
    • Approved Supplier List Management
    • Lead Auditor Qualification
    • Quality Agreement and Change Notice Agreements
    • Risk Identification, Assessment and Mitigation
    • Supplier Initiated Change Requests
    • Business Writing and Presentation
    • Computer Applications, including Microsoft Office Suite (Word, Excel, PowerPoint)
    • Problem SolvingHow we work at Philips
      • Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart - which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home - for our hybrid roles.
      • Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
        • Our hybrid working model is defined in 3 ways:
        • We believe in the importance of impactful collaboration: There's a certain energy when everyone's in the same room that can heighten idea generation and creative friction needed for problem-solving.
        • We embrace flexibility: Choosing where, when, and how to work can vary according to task and team schedules. Flexibility isn't office or online, it means choosing the space that works best for you, your teams, and our customers on a case-by-case basis.
        • We want to be at our best: The way we work, and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.Why should you join Philips?Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.Visit our careers website to explore what it's like working at Philips, read stories from our employee blog, find information about our recruitment process and answers to some frequently asked questions.It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person's relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran#LI-LI1

Keywords: Philips, Seattle , Sr. SQA Manager, Executive , Bothell, Washington

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