Quality Assurance Engineer

Overview

JOB SUMMARY:

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

Manufacturing

The Quality Assurance Engineer 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 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 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

The Quality Assurance Engineers are 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

RESPONSIBILITIES and GOALS:

The 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, Quality Assurance Engineers Shall Take Part 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.
• 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. 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, Mechanical, Electrical).
• 5+ years related Quality / Engineering work experience.
• 3+ 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
• Knowledge of Software within a device or Software as a Medical Device (SaMD).
• 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%.