Sr. Quality Assurance Engineer (Cloud Systems)

At Spacelabs Healthcare, you make a difference.

Every member of our worldwide team is integral in improving treatment and helping providers deliver exceptional care to their patients. From newborns to centenarians, more than 60 million people benefit yearly from the advancements we make in patient monitoring and management, care coordination, and clinical decision support.

Driven by the belief that anyone who seeks care could be a member of our own family, our team is dedicated to solving the greatest challenges the healthcare system currently faces, including the need to enhance the patient experience, improve population health, reduce costs, support care team well-being, and advance health equity. As part of our mission, we take pride in creating services and technologies that are personalized and tailored to support the needs of healthcare providers anywhere in the world.

While we may not be at a patient's bedside, their health is still in our hands

The Sr. Quality Assurance Engineer (Cloud Systems) shall provide leadership and support for QMS performance in many facets of business operations:

The Sr. Quality Assurance Engineer shall support Spacelabs Cloud products and be located in the Oklahoma City, OK office.

Design Control

To ensure the release of safe, effective and compliant medical devices, the Sr. Quality Assurance Engineer (Cloud Systems) shall provide Quality System Design Control mentoring to ensure product design teams' use of critical thinking. 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. He or she shall ensure that the proper activities are completed in a timely manner, performed and documented correctly, and readily offers guidance and support to ensure Quality System compliance.

The Sr. Quality Assurance Engineer (Cloud Systems) shall 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. The Sr. Quality Assurance Engineer (Cloud Systems) shall ensure that product Design Change activities move ahead in a timely and effective manner.

Manufacturing

The Sr. Quality Assurance Engineer (Cloud Systems) shall 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

The Sr. Quality Assurance Engineer (Cloud Systems) shall 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

The Sr. Quality Assurance Engineer (Cloud Systems) shall ensure that 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

Sr. Quality Assurance Engineer (Cloud System) is 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.

The Sr. Quality Assurance Engineer (Cloud Systems) 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, Sr. Quality Assurance Engineer (Cloud Systems) 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.
• Support the establishment of product cloud systems and configuration management.
• 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.
• Shall 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.

• Bachelor's degree in a Quality, Engineering, or related discipline (Computer/Software, Biomedical, Mechanical, Electrical)
• 7+ years related Quality / Engineering work experience.
• 5+ years of experience with medical device regulatory and quality and Quality Management Systems
• 2+ years of experience working with hosted / cloud product 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
• Knowledge of Software as a Medical Device (SaMD) or Software within a device required.
• 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 preferred.
• Creative problem solving, flexibility, and good negotiation skills.
• Some travel may be necessary both domestic and international, less than 5%.

#LI-Onsite

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.

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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.

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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.