Philips Director Quality & Compliance in Rancho Cordova, California

  • Directs activities of the Quality Department including but not limited to Operations, Document Control, CAPA, Complaints Investigations, Calibration, Supplier quality, and various other compliance related functions.

  • Ensures implementation, effectiveness, and integrity of the quality system that is compliant to all applicable standards and regulations to support the products on the market.

  • Leads all third party Quality System inspections, including FDA, notified bodies and all other regulatory bodies.

  • Assumes responsibilities of the Management Representative and as such chairs Management Review meetings.

  • Ensures quality metrics (e.g. post market, manufacturing and inspection) and key process indicators are identified, measured and action driven. Identifies unacceptable trends and applies suitable corrective action in order to meet strategic objectives.

  • Facilitates the NCR/CAPA process (e.g. assigns CAPA investigations, reviews CAPA plans, implementations and surveillance results).

  • Responsible for Site Quality Control (e.g. Incoming/In Process/Final Inspection, Non-conforming Material, and Calibration Systems) and Quality Management Systems (e.g. CAPA, Internal Audit, Management Review, Complaints, Employee Training, Document Control, Supplier Management, Remedial Action, etc.)

  • As appropriate serves as Lead Auditor; manage all internal audits; prepare for registrar audits; address non-compliance issues from both internal and external audits. Responsible for ensuring complete and sustainable implementation of an effective internal audit program.

  • Develop Quality planning/objectives, metrics and goals; lead efforts related to the company’s quality vision.

  • Manage site quality budget to ensure that all areas of quality are resourced and are capable to fulfill day to day operations. Responsible for hiring, firing, and employee corrective actions.

  • Maintain high standard of customer service to include investigation and resolution of quality complaints.

  • Utilize statistical data to support the development and manufacturing of new products.

  • Oversee calibration and testing program.

  • Develop quality-related training programs.

  • Provide support and where necessary lead corporate wide quality systems initiative.

  • To succeed in this role, you should have the following skills and experience

  • Requires a Bachelor's degree in a Technical, Science, or Engineering discipline.

  • Requires 10+ years’ experience in quality assurance/operations in a medical device industry.

  • Responsible for providing supervision and oversight for the quality manufacturing operations and personnel that support product manufacturing and day to day quality systems operations.

  • Manages exempt and nonexempt staff; makes hire, performance evaluation, termination, promotion and merit decisions

  • Requires 3+ years in a management or supervisory position preferably in quality function.

  • Must have demonstrated a proven experience in leading others with a proactive attitude.

  • Demonstrated knowledge and understanding of applicable FDA regulations and international standards and provides strategic direction to site leadership and functions in terms of ensuring a suitable and effective quality management system is present.

  • Demonstrated knowledge and experience of a wide range of medical devices such as interventional cardiology products and/or systems hardware.

  • Advanced Microsoft Office skills and ability to produce presentations and work formats to drive strategic and tactical programs.

  • Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties including Company management and outside business associates.

  • Able to work independently, make compliance decisions and direct other resources on compliance decisions related to complaint handling and safety reporting activities.

  • Must possess high performance skills of listening and learning, shared accountability, sense of urgency, self-growth and help others grow, continuous operational excellence/improvement and trust as part of being a leader.

  • Must be capable to work within a matrix type organization leveraging shared key talent to support site quality operations. The individual will be working closely with supplier quality, post market surveillance and Philips QMS teams to team up with matrix team members.

  • Ability to maintain confidentiality.

  • Ability to organize and prioritize workflow and to meet established timeframes and to maintain updated knowledge of procedures, products and activities of assigned area.

  • Ability to accurately proofread documents.

  • Ability to work under pressure.

  • Ability to coordinate the work of others.

  • Ability to interact with senior management on a regular basis including within the manufacturing site, the business unit and functional quality organization.

  • Ability to represent the Company at professional and business functions in a competent manner.

  • Problem solving and decision-making capability that includes systematically analyzing problematic situations and developing solutions consistent with organization objectives. Must have good hands on aptitude towards problem solving using lean and six sigma techniques and influence organization to drive to good root cause analysis.

In this role of Director of Quality & Compliance (based in San Diego, CA), you will be responsible for multiple manufacturing and design sites and leading all quality systems operations functions while reporting into Sr. Director of Quality in our Image Guided Therapy (IGT) Devices Business Unit. You will be our quality management representative and will be responsible for working closely with site leadership teams in driving day to day operations and ensuring compliance to the site procedures and regulatory requirements and timely and effective management of Quality Management System and the Key Performance Indicators (KPI).

You are responsible for

  • Directing activities of the Quality Department including but not limited to Operations, Document Control, CAPA, Complaints Investigations, Calibration, Supplier quality, and various other compliance related functions.

  • Ensuring implementation, effectiveness, and integrity of the quality system that is compliant to all applicable standards and regulations to support the products on the market.

  • Leading all third party Quality System inspections, including FDA, notified bodies and all other regulatory bodies.

  • Assuming responsibilities of the Management Representative and as such chairs Management Review meetings.

  • Ensuring quality metrics (e.g. post market, manufacturing and inspection) and key process indicators are identified, measured and action driven. Identifies unacceptable trends and applies suitable corrective action in order to meet strategic objectives.

  • Facilitating the NCR/CAPA process (e.g. assigns CAPA investigations, reviewing CAPA plans, implementations and surveillance results).

  • Site Quality Control (e.g. Incoming/In Process/Final Inspection, Non-conforming Material, and Calibration Systems) and Quality Management Systems (e.g. CAPA, Internal Audit, Management Review, Complaints, Employee Training, Document Control, Supplier Management, Remedial Action, etc.)

  • Serving as Lead Auditor; managing all internal audits; preparing for registrar audits; addressing non-compliance issues from both internal and external audits. Ensuring complete and sustainable implementation of an effective internal audit program.

  • Developing Quality planning/objectives, metrics and goals; lead efforts related to the company’s quality vision.

  • Managing site quality budget to ensure that all areas of quality are resourced and are capable to fulfill day to day operations. Responsible for hiring, firing, and employee corrective actions.

  • Maintaining high standard of customer service to include investigation and resolution of quality complaints.

  • Utilizing statistical data to support the development and manufacturing of new products.

  • Overseeing calibration and testing program.

  • Developing quality-related training programs.

  • Providing support and where necessary lead corporate wide quality systems initiative.

To succeed in this role, you should have the following skills and experience

  • Bachelor's degree in a Technical, Science, or Engineering discipline.

  • 10+ years’ experience in quality assurance/operations in a medical device industry.

  • Responsible for providing supervision and oversight for the quality manufacturing operations and personnel that support product manufacturing and day to day quality systems operations.

  • Manages exempt and nonexempt staff; makes hire, performance evaluation, termination, promotion and merit decisions

  • Requires 3+ years in a management or supervisory position preferably in quality function.

  • Must have demonstrated a proven experience in leading others with a proactive attitude.

  • Demonstrated knowledge and understanding of applicable FDA regulations and international standards and provides strategic direction to site leadership and functions in terms of ensuring a suitable and effective quality management system is present.

  • Demonstrated knowledge and experience of a wide range of medical devices such as interventional cardiology products and/or systems hardware.

  • Advanced Microsoft Office skills and ability to produce presentations and work formats to drive strategic and tactical programs.

  • Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties including Company management and outside business associates.

  • Able to work independently, make compliance decisions and direct other resources on compliance decisions related to complaint handling and safety reporting activities.

  • Must possess high performance skills of listening and learning, shared accountability, sense of urgency, self-growth and help others grow, continuous operational excellence/improvement and trust as part of being a leader.

  • Must be capable to work within a matrix type organization leveraging shared key talent to support site quality operations. The individual will be working closely with supplier quality,

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 improving 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

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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