Philips Quality Manager in Pittsburgh, Minnesota

Quality Manager

You are responsible for

You will formulate and implement the Business’ long-range quality, regulatory and compliance policy, and lead and direct organizational development and process. Improve in such a way as to ensure that the Business strategic policy and strategic growth targets are met. Ensures that all products to be released comply with all the relevant safety policies and regulations by implementing requirements, conditions and enablers in the Business. Establishes operational objectives and work plans, and delegate assignments to subordinates. Senior management reviews objectives to determine success of operation. Involved in developing, modifying and executing company policies that affect immediate operations and may also have company-wide effect.

SPECIFIC RESPONSIBILITIES

  • To formulate and implement the Business’ long-range quality, regulatory and compliance policy

  • Create Q&R awareness level as determined within the organization.

  • Enforces (a simplified) quality systems and harmonizes them across the Business sites and Sector; establish an effective Management Review process, including routine reporting.

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

  • Manages compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.

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

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

  • Manages product recall activities to include recall policies and procedures for the company. Additionally, manage product compliant activities and processes.

  • Direct the Audit Program for the organization

  • Drafts and manages the strategic improvement processes (‘breakthrough Program’) in the Business (One Page Strategy, Hoshin Plan).

  • Interact with all areas involved in the product development process, customer services and sales and marketing and provide direction and consultation

You are part of

This position resides in the Sleep & Respiratory Care Business Group, a business group of Philips HealthTech. We are highly dynamic, ambitious and agile within a fast changing industry.

Our vision is to work hand-in-hand with our clinical and consumer customers to transform the personalized healthcare market to meet the significant demands caused by the increase of chronic conditions and an aging society. Our mission is to improve the quality of life for consumers and patients through better awareness, diagnosis, treatment, monitoring, and management of their conditions.

Skills and experience

  • Bachelor Degree or equivalent required, advanced degree in STEM, Quality Management or Business Management preferred

  • 10 Years’ experience in business related fields, 5 years in a leadership role

  • Leader within a regulated industry (medical device industry experience preferred)

  • Experience in managing an organization through change

  • Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.

  • Distinguished by additional specialized knowledge in breadth and/or depth, as well as record of success in functional area. Viewed as an expert in the field.

  • Has expert level knowledge of company products and services.

  • Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.

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

We offer you

Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.

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.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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Quality Manager

You are responsible for

You will formulate and implement the Business’ long-range quality, regulatory and compliance policy, and lead and direct organizational development and process. Improve in such a way as to ensure that the Business strategic policy and strategic growth targets are met. Ensures that all products to be released comply with all the relevant safety policies and regulations by implementing requirements, conditions and enablers in the Business. Establishes operational objectives and work plans, and delegate assignments to subordinates. Senior management reviews objectives to determine success of operation. Involved in developing, modifying and executing company policies that affect immediate operations and may also have company-wide effect.

SPECIFIC RESPONSIBILITIES

  • To formulate and implement the Business’ long-range quality, regulatory and compliance policy

  • Create Q&R awareness level as determined within the organization.

  • Enforces (a simplified) quality systems and harmonizes them across the Business sites and Sector; establish an effective Management Review process, including routine reporting.

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

  • Manages compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.

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

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

  • Manages product recall activities to include recall policies and procedures for the company. Additionally, manage product compliant activities and processes.

  • Direct the Audit Program for the organization

  • Drafts and manages the strategic improvement processes (‘breakthrough Program’) in the Business (One Page Strategy, Hoshin Plan).

  • Interact with all areas involved in the product development process, customer services and sales and marketing and provide direction and consultation

You are part of

This position resides in the Sleep & Respiratory Care Business Group, a business group of Philips HealthTech. We are highly dynamic, ambitious and agile within a fast changing industry.

Our vision is to work hand-in-hand with our clinical and consumer customers to transform the personalized healthcare market to meet the significant demands caused by the increase of chronic conditions and an aging society. Our mission is to improve the quality of life for consumers and patients through better awareness, diagnosis, treatment, monitoring, and management of their conditions.

Skills and experience

  • Bachelor Degree or equivalent required, advanced degree in STEM, Quality Management or Business Management preferred

  • 10 Years’ experience in business related fields, 5 years in a leadership role

  • Leader within a regulated industry (medical device industry experience preferred)

  • Experience in managing an organization through change

  • Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.

  • Distinguished by additional specialized knowledge in breadth and/or depth, as well as record of success in functional area. Viewed as an expert in the field.

  • Has expert level knowledge of company products and services.

  • Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.

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

We offer you

Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.

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.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.

XLI-MR1