Philips Quality Manager (m/f) in Boblingen, Germany

Your challange

Your challenge will be to manage and develop the Patient Monitoring Quality Assurance, Quality Operations and Quality Engineering team. Ensure that all the Patient Monitoring Business has adequate support to achieve its business goal while promulgating and enforcing standards of operation.

Your responsibilities

  • Lead a team of quality engineering professionals within the PCMS Business Unit Patient Monitoring.

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

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

  • Provides cross-functional leadership for the Product Quality function in all aspects of the BU initiatives.

  • Enforces a quality systems, and harmonized across the Business sites and Sector; including routine reporting.

Your team

PCMS Patient Monitoring researches, designs, and develops best-in-class monitoring solutions, telemetry, clinical measurements, and clinical decision support systems that simplify clinician workflow, improve financial outcomes and help improve and save lives.

The Patient Monitoring Quality & Regulatory department supports patient care and monitoring solutions and ensures ww product approval and compliance with all applicable Regulations and requirements.

You will be leading a team of motivated quality engineering professionals.

Our offer

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 supporting an international business on various aspects. You will be successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).

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.

We are looking for

Essential:

  • Bachelor’s engineering degree with > 5 years of related experience, or a Master’s degree with > 3 years of related experience.

  • Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001.

  • 6+ years of related experience in a medical device or non-regulated industry.

  • Good interpersonal skills and strong communication skills, team player.

  • Strong English written and oral communication skills.

  • Demonstrated project management skills.

  • English (must), German (high want)

Preferred:

  • ASQ certification (or similar) as Certified Quality Engineer.

  • Leadership experiance

Philips encourages people with a disability to apply.

Your challange

Your challenge will be to manage and develop the Patient Monitoring Quality Assurance, Quality Operations and Quality Engineering team. Ensure that all the Patient Monitoring Business has adequate support to achieve its business goal while promulgating and enforcing standards of operation.

Your responsibilities

  • Lead a team of quality engineering professionals within the PCMS Business Unit Patient Monitoring.

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

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

  • Provides cross-functional leadership for the Product Quality function in all aspects of the BU initiatives.

  • Enforces a quality systems, and harmonized across the Business sites and Sector; including routine reporting.

Your team

PCMS Patient Monitoring researches, designs, and develops best-in-class monitoring solutions, telemetry, clinical measurements, and clinical decision support systems that simplify clinician workflow, improve financial outcomes and help improve and save lives.

The Patient Monitoring Quality & Regulatory department supports patient care and monitoring solutions and ensures ww product approval and compliance with all applicable Regulations and requirements.

You will be leading a team of motivated quality engineering professionals.

Our offer

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 supporting an international business on various aspects. You will be successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).

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.

We are looking for

Essential:

  • Bachelor’s engineering degree with > 5 years of related experience, or a Master’s degree with > 3 years of related experience.

  • Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001.

  • 6+ years of related experience in a medical device or non-regulated industry.

  • Good interpersonal skills and strong communication skills, team player.

  • Strong English written and oral communication skills.

  • Demonstrated project management skills.

  • English (must), German (high want)

Preferred:

  • ASQ certification (or similar) as Certified Quality Engineer.

  • Leadership experiance

Philips encourages people with a disability to apply.