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Quality Engineer Manager

Company: Siemens Mobility Austria GmbH
Location: newark
Posted on: May 3, 2021

Job Description:

Nows our time toinspire the future of healthcare together.

Siemens Healthineersis a leading global medical technology company with over 170 years ofexperience and18,000 patents.More than 48,000 dedicated colleaguesin over 70 countries are driven to shape the future of healthcare. We standwith our customers around the world to support them in delivering high qualitycare to their patients.An estimated 5 million patients across the globebenefit every day from our innovative technologies and servicesin theareas of diagnostic and therapeutic imaging, laboratory diagnostics andmolecular medicine, as well as digital health and enterprise services. This iswhat truly matters to us.

Join our team now atSiemens Healthineers as Quality Engineer Manager.

This is a role wellsuited to an ambitious professional, looking for the next step in their career.As a Quality Engineer Manager, you will be responsible for:

  • In your activities you will demonstrate subject matter expertise and the ability to provide guidance in the areas of change control, validation, design controls, design transfer activities, risk management, CAPA, audit, and statistical analysis techniques.
  • You will lead a team of Quality Engineers
  • You will serve as the SCM Quality Lead on Design Transfer and Change Control projects
  • You will own the processes for Change Control Review Board and Validation Review Board
  • You will own validation procedures and records as well as provide validation support (i.e. validation protocol drafting, approval, execution, train site personnel, etc)
  • You will manage the site validation master plan
  • You will identify opportunities for improvement for both internal and external processes, lead continuous improvement initiatives, support problem solving of complex production issues, and report on quality trends
  • You will independently perform full range of standard work as well as work collaboratively with cross functional team members across the organization

This position may suityou best ifyou are familiar with what is below, and would like to dodevelop your career with Healthineers

  • You have in depth working knowledge and practical application of process validation requirements(IQ,OQ, PQ) and Test Method Validation(TMV), change control, design controls, design transfer, risk management, CAPA, audit, and statistical process controls
  • You have in-depth knowledge of the requirements related to ISO 13485, FDA QSR, IVDR, and CGMP
  • IVD reagents and consumables experience preferred
  • You have proficient computer skills (MS Office Suite), statistical analysis skills using standard tools such as Microsoft Excel and Minitab, and organizational skills
  • You have proven the ability to lead complex projects and work collaboratively with others
  • You have experience problem solving and working in a fast-paced manufacturing environment
  • You demonstrate the ability to make decisions, prioritize, and communicate effectively across multiple levels
  • You strive to continuously improve and are passionate about working in the Medical Device Industry

Required skills tohave for the success of this role

  • Bachelors degree in Engineering, Science, or equivalent experience required
  • Strong leadership skills including leading a team of over 5 members
  • Minimum of 8-10 years of successful experience in the Medical Device Industry and Quality Engineering
  • Certified Quality Engineer (CQE) or Six Sigma Certification preferred
  • Willing to travel up to 20%

At SiemensHealthineers, we value those who dedicate their energy and passion to a greatercause. Our people make us unique as an employer in the med-tech industry. Whatunites and motivates our global team is the inspiration of our commonpurpose: To innovate for healthcare, building on our remarkable legacy ofpioneering ideas that translate into even better healthcare products andservices. We recognize that taking ownership of our work allows both us and thecompany to grow. We offer you a flexible and dynamic environment and the spaceto move beyond your comfort zone to grow both personally and professionally.

As anequal-opportunity employer we are happy to consider applications fromindividuals with disabilities.


Organization: Siemens Healthineers

Experience Level: Experienced Professional

Job Type: Full-time

Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here .

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here .

California Privacy Notice
California residents have the right to receive additional notices about their personal information. To learn more, click here .

Important note: For all job applicants looking to join us, please note Siemens does not ask for fees prior/during/after the application process. We do not ask for banking details or personal financial information in return for the assurance of employment. Similarly, please do not open documents in e-mails that appear to be sent by a Siemens recruiter unless you are sure you are being contacted by one of our professionals for an active application process.

Keywords: Siemens Mobility Austria GmbH, Newark , Quality Engineer Manager, Other , newark, New Jersey

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