Philips Quality Management System (QMS) Engineer in Wallingford, Connecticut
As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they improve.
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech-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).
Key areas of responsibilities for this role include:
Ensure compliance with the Quality Management System, in accordance with Philips Policy, applicable worldwide regulations and standards, for example FDA and ISO.
Assist with implementing and maintaining a single worldwide Quality Management System (QMS) strategy.
Support the business during internal and external audits.
Maintain the Quality Management System structure to ensure compliance to ISO 13485 medical device standards and regulations and 21 CFR 820.
Implement, maintain, and/or improve the quality system to meet or exceed regulatory and ISO compliance and conducts training as appropriate.
Manage the ECO process: collaborate with all affected associates, hold weekly change control board meetings, train associates, provide metrics and ensure that ECOs meet QMS requirements.
Maintain vigilance on key performance indicators (KPIs) for bi-annual documentation review and training completeness
Provide periodic updates and escalations on Document Control matters (e.g. backlogs, project statuses, etc.)
Routinely meet with functional managers to strategize and plan tactics to meet project/business objectives
Responsible for the maintenance and integrity of the Device Master Record, and Quality System documentation.
Responsible for the creation, maintenance and integrity of the Quality System, Procedures and Forms.
As 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 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 the world.
Location: In this role you will be the on-site in Wallingford, CT reporting into Philips’ Carlsbad, CA location.
We are looking for:
A person who is excited about the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience in challenging, 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 our brand touches every year.
Specific skill requirements for this role :
· Experience in the medical device industry and related FDA regulations
· Must have very effective communication skills, organization, and customer service skill
· Ability to work effectively with all levels
· Proven ability to lead a team and influence others
· QMS knowledge is a must
· Understanding of Configuration Management
· Understanding of Quality Management System (QMS)
· Understanding of the engineering change order (ECO) process
· CAD experience
· Knowledge of ISO standards
This role comes with a competitive compensation offering and a generous holiday/vacation offering, but that is 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 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 lines, 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, 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.