Sr Quality Assurance Engineer at Corindus, Inc. in Newton, Massachusetts

Job Description:

Our Global Team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what's possible in healthcare to help improve people's lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.


Our Culture : We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what's possible, to improve people's lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

We are currently looking for an ambitious Senior Quality Assurance Engineer to join our Endovascular Robotics business within Advanced Therapies. We are a global technology leader in robotic-assisted vascular interventions. We believe the combination of endovascular robotics, image guidance and dedicated devices will change the way neurovascular procedures will be done in the future, enabling better outcomes, and enabling our customers to provide better access to care.


As a Senior Quality Assurance Engineer you will be responsible for:

• Provide technical expertise in conducting investigations and making recommendations for targeted data and information collection as required for quality events.


• Monitor and analyze quality metrics to identify trends and drive continuous improvement.


• Interface with all departments in the organization in matters related to the quality system compliance.


• Propose, lead, initiate and follow-up on Corrective Action and Preventive Actions (CAPA).


• Assist in performing internal audits and provide support coordinating and participating in external audits (Regulatory, Notified Body, and Customer).


• Assist in the management of a Calibration and Preventative Maintenance program.


• Disposition non-conforming material (NCMR).


• Support product complaint investigations leading to root cause determination.


• Support updates to the Risk Management File (FMEA, Hazard Analysis, Post Market Surveillance Reports, etc.).


• Support the completion of validation protocols and test plans (IQ, OQ, PQ, test method and inspection method qualification).


• Support the development of an Internal Metrology program.


• Support manufacturing transfer activities, including the development and review of DMR/DHRs


• Review and as needed update QMS procedures (SOPs, Work Instructions, Forms) to reflect latest industry standards, guidance documents and best practices.


• Support the ongoing operation of ISO Class 8 Cleanroom/Controlled Manufacturing Environment.


• As appropriate, assist in supplier qualification activities (initial assessments and categorization).


• Other duties as assigned by manager.

Required skills to have for the success of this role:

• Bachelor's degree required in Engineering/Biomedical Engineering or Life Sciences (in lieu of degree additional work experience will be considered.)


• Minimum of 5 to 7 years of experience as a Quality Assurance Engineer in the medical device industry supporting Class II/III devices; QMSR/ MDD/MDR and ISO-13485 experience required; experience in supporting De Novo/PMA submissions is preferred.


• Notified Body/Regulatory Audit experience required; 13485:2016 Certified Quality Auditor (CQA) certificate is preferred.


• Must have experience in CAPA, NCMR, Internal/External Audits, calibration/preventive maintenance activities, risk management activities, and design controls. Experience as a CAPA Coordinator and/or Internal Audit Coordinator is preferred.


• Metrology experience with coordinate measuring machine (CMM) is preferred.


• Experience with single use device sterilization. Specific experience with ISO 11607-1:2019, ISO 11135:2014 is preferred.


• Experience with ISO Class 8 or greater cleanroom operations is preferred.


• Technical skills including the ability to read technical specifications and interpret industry standards and regulations.


• Effective and professional communication skills; Internal (engineering, operations, R&D, etc.) and external (customers, auditors and suppliers) required.


• Effective time/task management skills; excel working in a fast-paced environment.

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.


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If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.


If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.


As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.


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