QM-Quality Engineer 2 RAQA

QM-Quality Engineer 2 RAQA
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: 223782
Primary Location: United States-Massachusetts-East Walpole
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Associate's Degree / College Diploma
Travel Required: No
Division Description:
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/healthcare
Job Description:
Position Overview
The Quality Engineer 2 will report into the Manager of Quality at the Walpole facility. The primary responsibility of the Quality Engineer 2 position is the performance of the Quality Assurance (QA) release function for ADVIA Centaur and Atellica components. This includes:
? Reviewing ADVIA Centaur and Atellica component device history records for compliance against a defined set of attributes
? Resolution of any identified discrepancies with the responsible individual(s).
? Performance of SAP transactions
? Participation in daily production meeting
? Communication with notified body for the release of Annex II products
? Trending and tracking of data related to the QA release process
Additional responsibilities include:
? Lead/Participate in the identification and implementation of continuous improvement activities
? Creation, revision and approval of quality system procedures
? Coaching employees in quality knowledge in order to enhance and improve quality sense in the organization
? Support of third party inspections
? Assist in the internal audit program
Required Knowledge/Skills, Education, and Experience
? BS in Life Science or Engineering discipline with a minimum of 3 years of experience in the medical device or biotechnology industry
? Working knowledge of FDA Quality System Regulation (QSR) and ISO 13485
? Proven track record of interacting professionally and positively with employees at all levels of the organization
? Excellent organization and time management skills. The ability to manage and respond to changing priorities is critical.
? Proven track record of collaboration and the ability to drive positive change
? Excellent attention to detail
? Excellent verbal and written communication skills
? Competent with Microsoft Office suite (Excel, Word, Outlook, etc.)
Preferred Knowledge/Skills, Education, and Experience
? Prior experience performing internal quality system audits a plus
? Experience working in SAP a plus
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 .

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