Overview:
The Sr. Quality Assurance Engineer shall provide leadership and support for QMS performance in many facets of business operations:
Design Control
In this role, you will ensure that product development teams consistently apply strong critical thinking throughout the design and development process while maintaining deep expertise in Design Controls, Risk Management, Electrical Safety, and Usability Engineering. You will be responsible for ensuring all design-related activities are properly executed, accurately documented, and fully compliant with internal procedures and global regulatory expectations. You will review Engineering Change Orders (ECOs) and proposed design modifications to confirm they reflect sound engineering practices and uphold device safety and effectiveness. You will also oversee the efficient progression of design changes, ensuring all documentation is complete, traceable, and compliant. As an active participant in cross-functional design reviews, you will evaluate Design and Development Plans, Design Inputs and Outputs, verification and validation documentation, and design changes. Additionally, you will identify potential safety or performance risks and support appropriate risk management activities. Throughout the process, you will ensure that all design decisions are well justified, thoroughly documented, and aligned with regulatory and quality expectations.
Risk Management
you will actively participate in risk management activities in alignment with ISO 14971, supporting hazard analyses, FMEAs, and the creation and maintenance of all related risk management documentation. You will ensure that risk control measures are properly implemented, thoroughly verified, and supported by objective evidence. You will apply structured, risk‑based decision‑making to ensure product safety and regulatory compliance, while also ensuring that all risk–benefit evaluations are clear, comprehensive, and aligned with global regulatory expectations.
Material Review Board
The Sr. Quality Assurance Engineer 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 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
In addition, the Senior Quality Assurance Engineer will support key Quality Management System (QMS) administration activities related to design and development. This includes conducting internal quality audits to verify compliance with internal procedures and global regulatory expectations, as well as leading or supporting Corrective and Preventive Actions (CAPA), including verifying effectiveness and ensuring all remediation activities are properly documented. The role will manage Process Change Control for design‑related processes, ensuring changes are appropriately evaluated, documented, reviewed, and approved. The Senior QA Engineer will also support external audits and inspections by providing documentation, explaining processes, and representing relevant quality activities. Further responsibilities include assisting functional teams in understanding their quality obligations and maintaining alignment with the Spacelabs Quality Policy, as well as maintaining and improving QMS procedures, work instructions, and templates to ensure practices remain risk‑based, efficient, and compliant.
Responsibilities:
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:
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Ensure high quality of products and services, by implementing and maintaining the Quality Management System.
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Ensure that QMS activities are risk-based.
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Perform, report, and drive remediation from Internal Quality Audits and participate in third party audit and inspection activities (MDR, MDSAP, etc.).
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Routinely pursue more efficient and effective operations (continual improvement).
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Support the development teams of all business areas, working within the project teams on new or sustaining product development projects.
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Support the maintenance of the Essential Requirements Checklists / General Safety, Essential Requirements checklist and Technical Documentation Files.
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Assist with the compliance to changes to standards such as EN 60601-1, ROHS3, REACH, and Global regulatory requirements applicable to Spacelabs’ products.
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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.
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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.
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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).
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Support the manufacturing teams of all business areas, working within the teams on new or sustaining product and process improvements.
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Shall review and approve Device History Record (DHR) deliverables to ensure that production activities comply with Mandatory Device Master Record (DMR) requirements.
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Perform Manufacturing floor walkthroughs based on 7S criteria to support improvements and collaboration.
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Facilitate efficient and effective processing of Nonconforming Material Reports and Rework Orders.
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Create and update quality system procedure to achieve continuous compliance to ISO13485, European MDD/MDR, and MDSAP.
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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.
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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.
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Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork.
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Demonstrate behavior consistent with the company’s Code of Ethics and Conduct.
- It is the responsibility of every employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
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Duties may be modified or assigned at any time to meet the needs of the business.
This role will work with R&D engineering 100% and therefore he/she has to have strong experience in following areas:
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Design Control, new product development
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Review and approve engineering changes representing Quality
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Working knowledge of ISO 13485
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Maintain Design History File (DHF), Technical Files, Risk Management
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Experience with ISO 14971 Risk Management.
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Knowledge of Software with a Device or Software as a Medical Device
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Experience in Corrective and Preventive Action (CAPA)
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Experience in internal audits
Qualifications:
- Bachelor’s degree in a Quality, Engineering, or related discipline (Computer/Software, Biomedical, Mechanical, Electrical).
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7+ years related Quality / Engineering work experience.
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5+ years of experience with medical device regulatory and quality and Quality Management Systems
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Experience maintaining Technical Files, GSRPCs, Risk Management Files, Usability Engineering Files, Design History Files, MVP's, and Change Control documentation.
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Experience with statistical analysis
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Knowledge of Software as a Medical Device (SaMD) or Software within a device required.
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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.
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Self-motivated and organized.
DESIRABLE
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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.
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Experience with medical device electrical safety standards.
- Creative problem solving, flexibility, and good negotiation skills.
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Some travel may be necessary both domestic and international, less than 5%.
Physical Requirements:
- Standing: 20-45%
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Bending: 15-20%
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Sitting: 70-75%
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Stooping: 5-10%
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Reaching: 15-20%
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Walking: 5-10%
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Lifting: (0 – 25lbs) < 5%
