Siemens DCU Quality Engineer 3 - POC in Norwood, Massachusetts
DCU Quality Engineer 3 - POC
Job Family: Quality Management
Division: Siemens Healthineers
Business Unit: Point of Care
Requisition Number: 209393
Primary Location: United States-Massachusetts-Norwood
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%
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
Specific Requirements POSITION OVERVIEW: The Quality Engineer, Designated Complaint Handling Unit (DCU) will be responsible for the integrity of POC complaint files and the complaint handling process, and will contribute to measurable improvements in complaint handling, product quality, and the customer experience. The DCU is responsible for all safety complaints, and confirmed product complaints This role will work closely with a cross-functional team, including - R&D, Product Health Teams, Manufacturing, Headquarters Support, Manufacturing, Procurement, OEM Supplier Management and Commercial Product Engineering. RESPONSIBILITIES: • Serve as a Subject Matter Expert for the complaint handling process. • Coordinate complaint-related activities across multiple functions and sites within POC. • Provide complaint handling and quality engineering expertise and consultation to significant / complex projects. • Lead Escalation Review Committee (ERC) meetings for confirmed product complaints. • Contribute to product safety, product quality, and customer satisfaction related decisions (both data-based and risk-assessment-based decisions). •.Ensure prompt escalation and complete documentation of product safety complaints by requesting feedback to regional units as needed. •.Ensure complaint documentation and records are complete and in compliance with regulatory requirements prior to closure. • Participate and support internal, external audits and inspections • Perform confirmed complaint trending • Ensure Post Market Surveillance activities are completed • Provide input on local DCU procedures and process improvements EDUCATION/SKILLS/EXPERIENCE: • Minimum BA/BS degree in science or other technical field • Strong technical knowledge of POC products • Direct experience handling complaints in the medical device industry • Experience participating in internal and external inspections (e.g., FDA, LRQA) • Strong organizational and time management skills • Strong communication skills (written, oral, and listening) • Knowledge on CAPA, complaint investigation, and field action processes • Ability to influence without authority • Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and give oral presentations CERTIFICATIONS/LICENSES/REGISTRATIONS • Certified Quality Engineer or Certified Reliability Engineer (ASQ or equivalent) and/or • Clinical background and/or field experience desirable OTHER/SKILLS AND ABILITIES • Demonstrated knowledge and application of QSR and international standards • Ability to influence without authority • Strong leadership skills TRAVEL • 10% General Requirements Job Family Responsibilities: Education: BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas. Knowledge and Experience: Demonstrates and applies comprehensive knowledge in field of specialization to the successful completion of complex assignments. Demonstrates advanced knowledge of concepts, practices, and procedures of particular area of specialization. Demonstrates significant knowledge of organization's business practices and issues faced and contributes to problem resolution of those issues. Typically 8-10 years of successful experience in related field and successful demonstration of Key Responsibilities and Knowledge as presented above. Advanced degree MAY be substituted for experience, where applicable. Key Working Relationships: Primarily intra organizational contacts and external contacts.
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 .