Sr. Quality Assurance Engineer

Overview At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients. Why work at Spacelabs? Because lives depend on you The Lead (Senior) Quality Assurance Engineer is responsible for the establishment, maintenance, operation, and effectiveness of the Spacelabs Quality Management System. The Quality Management System (QMS) is intended to ensure effective and efficient operation of the organization, including assurance of the quality of the products and services offered by Spacelabs. Lead Quality Assurance Engineers are responsible for maintaining a quality- and results- centric company culture that drives customer satisfaction, employee satisfaction, meaningful regulatory compliance, and continually improving operational excellence. This shall be done by inspiring employees to achieve to their potential, fostering the achievement of company goals by organized teamwork, and demonstrating operational excellence via leadership to support company quality policies and goals. They also seek to maintain operations that efficiently and effectively surpass strategic business planning and performance objectives. Preference will be given to local candidates, but we are open to non-local/ remote candidates as well. Responsibilities The Sr. Quality Assurance Engineer will provide leadership and support for QMS performance in many facets of business operations: Design Control To ensure the release of safe, effective and compliant medical devices, the Sr. Quality Assurance Engineer shall provide Quality System Design Control mentoring to ensure product design teams' use of critical thinking. They will be well versed in all aspects of Design Controls, Risk Management, Electrical Safety and all associated processes, policies, procedures, and records. Ensure the proper activities are completed in a timely manner, performed and documented correctly, and readily offers guidance and support to ensure Quality System compliance. Review all Engineering Change Orders and proposed changes or improvements to ensure sound engineering practice, effective and adequate design, product safety, and Quality System compliance. Ensure product Design Change activities move ahead in a timely and effective manner. Manufacturing Monitor and ensure efficient and effective product manufacturing processes, facilitating adequate manufacturing work instructions, material control, nonconforming material handling, inspection, and finished goods handling. Material Review Board Facilitate efficient and effective processing of Nonconforming Material Reports and Rework Orders. Process performance metrics shall be captured, monitored, and reported to ensure timely and effective MRB throughput and minimized quarantine back log. Installation and Service Ensure post-market activities ensure intended device performance. Service and support activities must be adequately documented, attention escalated to facilitate defect handling, and product performance and performance trends assessed to understand and drive improvement opportunities. QMS Administration Responsible for conducting QMS administration activities, including Internal Quality Audits, Corrective and Preventive Action, Process Change Control, Exception Handling, process improvement and maintenance, supplier quality, external audit support, and related activities. Responsibilities & Goals The Sr. Quality Assurance Engineer shall follow the guidance of RA/QA Management and help other organizational functions understand and fulfill their obligations to meet quality objectives, systemic responsibilities, and customer requirements, as defined by Executive Management in the Spacelabs Quality Policy. As part of maintenance of the Spacelabs Quality Management System, Senior Quality Assurance Engineers shall partake in some or all of the following responsibilities: Ensure high quality of products and services, by implementing and maintaining the Quality Management System. Ensure that QMS activities are risk-based. Perform, report, and drive remediation from Internal Quality Audits and participate in third party audit and inspection activities (MDR, MDSAP, etc.). Routinely pursue more efficient and effective operations (continual improvement). Support the development teams of all business areas, working within the project teams on new or sustaining product development projects. Support the maintenance of the Essential Requirements Checklists / General Safety, Essential Requirements checklist and Technical Documentation Files. Assist with the compliance to changes to standards such as EN 60601-1, ROHS3, REACH, and Global regulatory requirements applicable to Spacelabs' products. Provide Quality System guidance to his or her product design teams. He or she shall be well versed in all aspects of Design Controls, Risk Management, Electrical Safety and all associated processes, policies, procedures, and records. Collaborate with engineering to determine and execute engineering design and development planning in support of regulatory submissions. Review Engineering Change Requests and Engineering Change Orders to identify critical components, defects in drawings/schematics, effective and adequate design documentation, product safety, and Quality System compliance. Assist with the creation, maintenance, and performance of QMS change management tools: Corrective Action Reports (CAR's), Preventive Action Reports (PAR's), and Process Change Orders (PCO's). Support the manufacturing teams of all business areas, working within the teams on new or sustaining product and process improvements. Shall review and approve Device History Record (DHR) deliverables to ensure that production activities comply with Mandatory Device Master Record (DMR) requirements. Perform Manufacturing floor walkthroughs based on 7S criteria to support improvements and collaboration. Facilitate efficient and effective processing of Nonconforming Material Reports and Rework Orders. Create and update quality system procedure to achieve continuous compliance to ISO13485, European MDD/MDR, and MDSAP. Assist in the preparation and submittal of registration applications. May assist in the preparation of IDE, 510(k), CE Mark, and other similar regulatory filings. Participate in cross-functional design teams to review all Design and Development Plans, Design Inputs, Design Outputs, V&V documents, and Design Changes including Defect Reports. Senior Quality Assurance Engineers shall recognize potential impacts to health or device efficacy ("Safety Issues"), support criticality assessment needed to ensure the application of reasonable and required Risk Management, Verification and Validation, and adequate record-keeping practices. Upholds the Company's core values of Integrity, Innovation, Accountability, and Teamwork. Demonstrates behavior consistent with the Company's Code of Ethics and Conduct. Ensure that direct report(s) are trained and evaluated on their knowledge and adherence to the Company's values, Code of Ethics and Conduct, and applicable compliance policies. It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects for corrective action to be implemented and to avoid the recurrence of the problem. Duties may be modified or assigned at any time to meet the needs of the business. Qualifications Bachelor's degree in a Quality, Engineering, or related discipline (Computer/Software, Biomedical, Electrical). 7 years related Quality / Engineering work experience. 5 years of experience with medical device regulatory and quality and Quality Management Systems. Experience maintaining Technical Files, GSRPCs, Risk Management Files, Usability Engineering Files, Design History Files, MVP's, and Change Control documentation. Experience with statistical analysis. Experience working with teams under design controls and during new product development to follow the QMS and comply with current regulations and standards. Proven ability to communicate effectively with staff at all levels of the organization. Self-motivated and organized. DESIRABLE: Experience acting as a Change Agent. Experience with FDA 21 cfr 820, 21 cfr 11, 21 cfr 806, MDD, MDR, MDSAP, EN ISO 13485, EN ISO 14971, IEC 62366-1, EN ISO 15223, EN ISO 20417, EN 62304, Cybersecurity, IEC 60601-1, ISO 27001 and 14001. Experience with medical device electrical safety standards. Some travel may be necessary both domestic and international, less than 5%. LI-Onsite LI-Remote LI- Hybrid Please review our benefits here: Life at OSI The specific programs and options available to any given employee may vary depending on eligibility factors such as geographic location and date of hire. Please note that the salary information shown above is a general guideline only. Salaries are based upon candidate experience and qualifications, as well as market and business considerations. NOTICE TO THIRD PARTY AGENCIES OSI Systems, Inc. and its subsidiaries (collectively "OSI") does not accept unsolicited resumes from recruiters or employment agencies. If any person or entity, including a recruiter or agency, submits any information, including any resume or information regarding any potential candidate, without a signed agreement in place with OSI, OSI explicitly reserves the right to use such information, and pursue and/or hire such candidates, without any financial obligation to the person, recruiter or agency. Any unsolicited information or resumes, including those submitted directly to hiring managers, are considered and deemed to be the property of OSI. Equal Opportunity Employer - Disability and Veterans EEO is the Law Poster Link: https://www.eeoc.gov/sites/default/files/migrated_files/employers/eeoc_self_print_poster.pdf OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others.