Siemens Healthcare Diagnostics is looking to ensure products are designed and produced to meet or exceed customer requirements and expectations by developing, implementing, maintaining, and improving systems. The candidate will ensure consistent implementation and compliance to the Siemens Healthcare Diagnostics Quality System and external regulations.
Requirements
- Strong knowledge of FDA Quality System Regulation (QSR) with an emphasis on Process Validation and Design Controls; ISO 13485; and ISO14971.
- Proven experience providing quality engineering leadership to project teams in the areas of Design Controls, Process Validation and Control, and Risk Management.
Responsibilities
- Serving as the quality representative on the element team during the technical transfer from design to manufacturing.
- Supporting ongoing product and process changes post-manufacturing.
- Providing leadership in design control, process validation, and risk management within a Class II and Class III IVD reagent manufacturing facility.
- Provides independent oversight and review of project deliverables throughout the lifecycle.
- Actively participate in the change management process to ensure products continue to meet customer requirements
- Collaborate as part of a cross-functional team alongside business and engineering disciplines.
Other
- BS in Life Science or Engineering discipline with a minimum of 5 years of experience in the medical device, pharmaceutical or biotechnology industry.
- The annual base pay for this position is: Min $99,700 - Max $149,500
- Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.
- If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan.
- The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.
