Siemens Quality Engineer 3 in Flanders, New Jersey

Quality Engineer 3

Locations:Flanders, New Jersey

Job Family: Quality Management

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Job Description

Division: Siemens Healthineers

Business Unit: Laboratory Diagnostics

Requisition Number: 225500

Primary Location: United States-New Jersey-Flanders

Assignment Category: Full-time regular

Experience Level: Senior level

Education Required Level: Bachelor's Degree

Travel Required: No

Division Description:

At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.

Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.

Job Description:

Quality Engineer 3 – Design Transfer Engineer

Siemens US Talent Acquisition

Position Overview

This position is for a Quality Engineer 3, reporting to the Quality Engineering Manager, with primary responsibility for Design Transfer/Quality Engineering Project activities in manufacturing. This person will work with cross functional teams to determine Design Transfer/Change Control activities required for projects as well as engineering and process changes. This role requires excellent organizational skills, analytical problem solving skills, the ability to effectively communicate at a technical level as well as with management, and in-depth understanding of quality system requirements.

The person in this role will:

  • Participate on Design Transfer/Change Control projects as the Quality Assurance Lead

  • Lead improvement initiatives for Quality Assurance

  • Independently perform full range of standard work

  • Identifies and resolves more complex problems and applies problems-solving skills in order to deal with most situations

  • Chair Process Change Review Board meetings

Responsibilities

This position will be responsible for being the Quality Assurance lead on Design Transfer and other change projects, including engineering and process change projects.

  • Serve as Core Team member on Design Transfer projects

  • Lead/Actively support cross-functional teams in execution and reporting of quality improvement projects with a focus on overall process improvements

  • Use statistical and risk management techniques

  • Actively participate in internal audit process

  • Write/support creation of validation plans, protocols and reports

  • Support departments with maintaining compliance with applicable standards and regulations

  • Provide guidance for changes, including guidance on validation requirements

  • Participate as subject matter expert in internal and external audits

Required Knowledge/Skills, Education, and Experience

  • In depth understanding of process validation requirements (IQ/OQ/PQ) and TMV, with ability to develop and support creation of protocols and reports

  • Familiarity with statistical analysis techniques

  • In-depth knowledge of requirements related to ISO 13485 and FDA QSR

  • Strong knowledge of Risk Management and Design Controls/Design Transfer/Change Control

  • Experience with product transfers and new product development projects

  • Strong organizational skills and ability to prioritize

  • Experience working in medical device or regulated industry

  • Proficient with Microsoft Excel, including use of pivot tables

  • Perform trend analysis using standard software such as Minitab

  • Ability to communicate effectively within a technical environment

Preferred Knowledge/Skills, Education, and Experience

  • Bachelor’s degree in Science or Engineering field of study

  • Certified Quality Engineer (CQE), Six Sigma Certification, or Project Management experience preferred

  • 5-8 years of successful experience in medical device and quality engineering, and successful demonstration of Responsibilities and Knowledge as listed above

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, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, 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 at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

Pay Transparency Non-Discrimination Provision

Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf .