Job TitleSQA Software
This position will be responsible for assisting the Software Supplier Quality team in processing supplier assessment documentation. The ideal candidate will be comfortable communicating with software and cloud based suppliers of all sizes and maturity levels. The candidate will be responsible for verifying supplier files are complete and ready for formal review as well as ensuring information requests and follow-ups are done in a timely manner. Must be adept at applying validation and qualification principles and best practices to a task and delivering quality results. Detailed understanding of QMS structure, software development life cycles, programming standards and cloud based delivery and management required.
- Works within purchasing control processes, procedures & systems to ensure compliance with applicable regulations · Sets/updates purchasing control requirements to suppliers, classification of suppliers, and risk categorization · Ensures integration and validation of purchasing procedures with supporting IT and data applications for effective operationalization · Owns supplier qualification, audit, and assessment. This includes supporting and defending Philips in external and internal inspections/audits, and supporting the closure of regulatory compliance gaps at suppliers and suppler non-conformances. · Participates in supplier selection process; maintain the Approved Supplier List (ASL) and documented evidence of evaluation records · Actively monitors supplier quality metrics, quality agreements with critical suppliers, and quality of supplier records and drives supplier quality management review with relevant stakeholders· Actively participates in supplier quality related communication and feedback
- Leads KAR related assignments within BG/markets/SVAL. · Shapes relevant Philips Excellence practices to identify and solve major supplier quality issues where complex analysis of Supplier Quality data is required. · Has a multidisciplinary · approach and knowledge of supplier quality principles, theories and concepts. · Formulates the Supplier Quality solution by · combining previous experiences but by composing newly acquired · Supplier Quality knowledge. · Leads multidisciplinary · change projects in Supplier · Quality, managing a number of people. · Introduces Supplier Quality methods/procedures that · are new for the organization. · Applies advanced Supplier Quality process principles to multiple tasks.
- Assures 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.
We are looking for
- Expertise in the following MS applications: Word, Excel, Sharepoint, Outlook, One Drive
- Excellent communications skills (written and verbal)
- Comfortable following up with suppliers, collecting additional information ensuring timelines are met
- Ability to track down sources internal/external for missing or incomplete information
- Develop internal contacts and resources to aid in data gathering and processing of supplier related files
- Able to manage multiple workflows and communication strings
- Comfortable with managing external influences and competing requests for service while maintaining focus on in process tasks
- Ability to assume ownership of in process work product and driving to closure
- Negotiate and identify resolutions to bring closure to outstanding issues
Must have a professional background in one or more of the following:
- Software development
- Cloud technologies
- Software validation
- Supplier auditing/quality
- Understanding of ISO certifications and SOC reporting standards a Plus+
- Knowledge of FDA regs. a Plus++
- Must be able to identify deficiencies as compared to a standard and close any gaps
- Must be detail oriented, comfortable with reviewing documentation against defined standards
- 8-10 years professional experience
- Experience with CAPAs and SCARs a Plus+
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, 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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