Philips Q&R Site Manager Ultrasound Reedsville in Reedsville, Pennsylvania

We invite you to join Philips Healthcare as an experienced Q&R Site Manager Ultrasound/Transducer in our Reedsville, PA location

To support of Philips’ commitment to Quality, the recently restructured Q&R organization has strengthened interfaces with Business Group and Market leadership. Our key Q&R Capabilities focused on Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit and Post Market Surveillance empower us to partner with and have a positive impact on the business, and on health technologies that improve the health, well-being and care for people around world. Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our healthcare focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA). You will be responsible for ensuring Reedsville site Quality Compliance and driving quality process across that Ultrasound / Transducer Business and will become a member of the Ultrasound Q&R Management Team, reporting directly to Head of Q & R for Ultrasound.

Responsibilities:

  • Ensures that all products to be released comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions and enablers in the Business.

  • Establishes operational objectives and work plans, and partners with managers to identify and project manage resources to achieve goals.

  • Is involved in developing, modifying and executing company policies that affect immediate operations and may also have company-wide effect

  • Regularly interacts with Transducer R&D and Operations &D management levels on matters concerning several functional areas, divisions, and/or customers.

  • Has the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.

  • Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.

  • Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.

  • Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.

  • Enforces quality systems and harmonizes them at the Business site; participate in an effective Management Review process, including routine reporting.

  • Introduces and implement the quality processes and tools required to ensure product quality and customer satisfaction.

  • Manages the review and approval of finished products manufactured for and by the company in accordance with their approved specifications.

  • Manages all inspections and questions relating to the operation of the manufacturing sites in coordination with all other applicable company groups.

  • Provide leadership to ensure product quality and quality system compliance to ISO 13485 and FDA Quality System Regulation (21 CFR 820), Canadian CMDCAS, Japan PAL regulation and all other worldwide medical device quality regulations.

  • Represent the business during any audit processes, internal or external. Drive compliance across all functions of the business and ensure preparedness for any audits. Take action on any audit findings, to reinforce compliance or remedial action on any unsatisfactory findings.

  • Identify and implement best practices to improve efficiency and maintain compliance and lead the function in continuous process improvement.

  • Ensure strategic alignment of quality and regulatory activities with business objectives to ensure continued compliance and good audit outcomes.

Reedsville, PA:

Partnering with Transducer manufacturing sites in Andover MA and Shanghai PRC, the Reedsville site employs 400 employees and is currently undergoing an expansion to meet increasing demand.

We are looking for:

A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience in challenging and often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life for the billions of people the Philips brand touches each year.

Specific skill requirements for this role include:

· Bachelor's degree (Science, Engineering or similar technical discipline) preferred

· 7-10 years’ experience in Quality / Regulatory roles support R&D and Manufacturing

· Expertise and experience in Quality principles and tools, e.g. Six Sigma Blackbelt

Our offer:

This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, and protected veteran or marital status.

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.

 

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