Senior QMS Engineer
You are responsible for:
- Ensures external and internal audit readiness and provides support during external and internal audits.
- Supports certification relationship with Notified Body as appropriate.
- Reviews QMS and Engineering changes as well as Quality plans to ensure compliance/conformanceto FDA regulations and other Regulatory Agency and consensus standard requirements.
- Ensures adequate service levels and quality for document control, records management, software validation, CAPA, Quality Planning, Management Review QMS processes, monitoring and assurance of process performance.
- Represents QMS/Engineering Change processes and records to regulatory agencies as required.
- Owns QMS CAPAs, develops adequate and defensible root cause analyses and action plans; completes plans to schedule.
- Actively assists in managing a program of CAPAs; accountable for timely and comprehensive corrective and preventive management of issues/opportunities.
- Actively assists in managing a program of Quality Plans; accountable for plan accuracy and on-schedule plan closure.
- Proactively identifies areas of emerging risk and advises on directions for future areas of analysis/development.
- Acts as QMS competence expert, coaching and developing skills and knowledge within the QMS team.
- Supports the move toward the Philips Excellence Process Framework for the transformation the business to the Philips Business System including the Philips Integrated IT Landscape
- Promoting Q&R awareness level as determined within the organization.
- Managing the enforcement of standardized quality systems across the Business; ensuring deployment of strategic projects & E2E PIL Solutions to schedule
- Establishes an effective Management Review process, including routine reporting.
- Participates in Quality & Regulatory initiatives as a cross functional contributor.
- Creates PQMS transformation awareness and establishes the Philips Business System, manages all activities under the PQMS governance.
To succeed in this role, you’ll need a customer-first attitude and the following:
In return, we offer you:
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.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.