Siemens Quality Engineer 5 in Tarrytown, New York

Quality Engineer 5

Multiple Locations:Tarrytown, New York; Plainfield, Indiana; Flanders, New Jersey; East Walpole, Massachusetts; Elkhart, Indiana

Job Family: Quality Management

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Job Description

Division: Siemens Healthineers

Business Unit: Laboratory Diagnostics

Requisition Number: 228173

Primary Location: United States-New York-Tarrytown

Other Locations: United States-Indiana-Elkhart, United States-Massachusetts-East Walpole, United States-New Jersey-Flanders, United States-Indiana-Plainfield

Assignment Category: Full-time regular

Experience Level: Senior level

Education Required Level: Bachelor's Degree

Travel Required: 20%

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:

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.

Senior Global Quality Management Engineer Position for the Laboratory Diagnostics organization

Position Overview :

Thisactive position requires an experienced individual within a regulated environment who has demonstrated ability to develop, implement and maintain the management review process; including extensive knowledge of key input sources such as complaint handling, audits, regulatory authorities reporting, monitoring and measurements of processes / product along with corrective and preventive action (CAPA) processes (e.g. CFR §820.90, §820.100, ISO 13485 §5.6, 8.4 and 8.5) for the Laboratory Diagnostics (LD) organization.

In addition, this position will require an experienced individual to ensure the product hold process is established, effective and aligns with various reporting sources for complete reconciliation of all products manufactured and shipped.

Summary of Duties; include, but not limited to:

  • Establishes a harmonized evaluation of key process indicators for the responsible processes across the organization.

  • Communicates and collaborates with all manufacturing, research and development sites to establish, implement and maintain a program that identifies key process indicators, performance metrics to improve the products, processes or the quality system.

  • Collaborates with all sites, distribution centers and information technologies to verify the product hold application throughout the supply chain spectrum.

  • Provides analysis of process indicators and leads efforts of continual improvement.

Responsibilities

In this this role, the individual directs, implements and maintains the Management Review, Product Hold processes for the LD organization where specific responsibilities include:

  • Educates the subject matter experts in the objectives, process steps necessary to identify key process indicators which reflect the process health pertinent to business objectives.

  • Ensures the collection and analysis of quality information from various quality systems to determine trends in quality and the health of the quality system.

  • Provides periodic status reports on the trends and identifies potential areas of high compliance risk to the LD organization.

  • Represents functional areas of responsibility during external audits.

  • Participates in the internal audit process of the LD organization.

  • Owns the Management Review procedures and work instructions for the LD organization.

  • Maintains CAPA management skills and awareness of current and developing CAPA requirements; including the monitoring of external regulatory actions to proactively communicate industry trends.

Required Knowledge/Skills, Education, and Experience

Experience: A minimum of 10 years in the medical device industry with at least 5 years in a quality system management role.

Education: A minimum of a 4 year degree, preferably in an engineering or science discipline.

Skills/Knowledge/Experience:

· Proven understanding and practical application of medical device quality system regulations ; including, but not limited to direct management of:

o Management Review process,Non-conformance management, and CAPA processes

· Experience hosting/participating in FDA and Notified Body inspections

· Understanding of the principles of Risk Management and a demonstrated knowledge of the application of risk assessment techniques, ISO 14971, such as FMEA.

· Proficient technical business software knowledge with strong analytical skills for identifying the frequency, severity and distribution of trends.

Preferred Knowledge/Skills, Education, and Experience

Management / Leadership Skills:

  • Demonstrates leadership to others in the organization through influence, innovative practices and teaching skills to foster a corporate culture of responsiveness, compliance awareness and continual improvement.

  • Leads, facilitates and coordinates with non-quality management functions; able to motivate, achieve commitments as expected and promotes the management review process.

  • Interacts effectively with senior management on a regular basis and in an efficient manner to expedite time requirements.

Problem Solving / Analytical Skills:

  • Utilizes excellent problem solving methodology, industry accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issues.

  • Comprehends and solves complex compliance related problems and provide a variety of concrete solutions where only limited standardization and precedent exists.

  • Proficient in coordinating cross functional efforts to correct processes when requirements are not met.

  • Analyzes, summarizes and interprets quality system data, draw conclusions and make appropriate recommendations.

  • Recommends effective solutions to problems, collaborating with individuals across the organization.

Quality / General Skills:

· Excellent written and verbal communication skills.

· SQ certification (e.g., CQA or CQE) highly desirable.

· Prior experience with quality data trending and statistical analysis of data.

· Prior experience in an IVDD manufacturing or pharmaceutical environment is a plus.

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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 .