Siemens Quality Engineer 1 in East Walpole, Massachusetts

Quality Engineer 1

Locations:East Walpole, Massachusetts

Job Family: Quality Management

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English (US)

Job Description

Division: Siemens Healthineers

Business Unit: Laboratory Diagnostics

Requisition Number: 210161

Primary Location: United States-Massachusetts-East Walpole

Assignment Category: Full-time regular

Experience Level: Entry level

Education Required Level: Bachelor's Degree

Travel Required: 10%

Division Description:

Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.

With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.

For more information, please visit: http://www.usa.siemens.com/healthineers

Job Description:

Position Overview

The Quality Engineer 1 position will be responsible for a wide variety of activities to ensure compliance with applicable regulatory requirements, such as documentation reviews, conducting quality assessments, material investigation report reviews, data analysis and validation activities. The primary focus of this position will be quality support for quality system implementation and validation execution at an IVD manufacturing facility to be built in China. This position is based in Walpole and will report to the China Quality System workstream lead/manager also in the Walpole facility.

Responsibilities

In this role the individual will be responsible for participation on individual validation and qualification activities for process, equipment, facilities and utilities of an IVD manufacturing facility to be built in China. In addition, the individual will work closely with the quality assurance manager to develop and implement quality system documents for China facility to ensure they are complying with identified standards and regulations.

Specific responsibilities include but are not limited to:

  • Support in development of site Validation Master Plan.

  • Create and develop individual quality and validation protocol and report

  • Work with Engineering on specific equipment, facility and utility validation plans and reports.

  • Ensure that all qualification/validation plans, protocols and reports are complete, accurate and compliant with applicable requirements, including those of the China FDA.

  • Analyze and evaluate quality data, identify deficiencies and continuous improvement opportunities. Escalate quality problems to management and drive for the solutions.

  • Provide support to the China Quality team to ensure that the Quality Management System is fully implemented in the organization.

  • Assist in the internal audit program to help ensure the compliance of the internal departments to applicable regulations as required.

  • May require some travel to China.

Required Knowledge/Skills, Education, and Experience

Experience: A minimum of 1-2 years in the medical device, biotechnology or pharmaceutical industry, in a Quality Engineer or Validation Engineer role.

Education: A minimum of a 4 year degree is required.

Skills/Knowledge/Experience:

  • Knowledge of CFR 21 Part 820 (QSR), ISO 13485, , and other domestic and international regulations that may apply

  • Experience in the application of production and process controls including process validation, test method validation, process control plans, statistical process control, risk management and statistical tools.

  • Excellent verbal and written communication skills.

  • Must be able to work collaboratively with other project team members.

Preferred Knowledge/Skills, Education, and Experience

  • Prior experience with facility start-up/qualification projects.

  • A quality engineering certification from the American Society for Quality other qualifying organization is required. Examples include the CQE, CRE, etc.

  • Fluent in Chinese is a plus

  • Knowledge of CFDA IVD GMP requirements

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 .