The Quality Assurance (QA) Specialist supports the establishment and maintenance of the Spacelab’s Quality Management Systems in compliance with medical device laws, regulations and standards. The individual is responsible for introducing and maintaining quality system procedures, system improvements, corrective and preventive actions (CAPA), internal audits, nonconforming material reports (NMR), change orders, training, product design and development, and unique device identifier labeling.

***This is an on-site position located in Snoqualmie, Washington. You will be required to work on-site up to 4 days per week***

• Authors and maintains Quality Management System policies, procedures, work instructions, and templates.
• Ensures that the QMS is established and maintained to ensure continuous compliance with the FDA Quality System Regulations (QSR), ISO13485 and 14971, European MDR, MDSAP, Canadian, and other OUS regulatory requirements.
• Maintains QMS controls to meet company development and strategic objectives.
• Drives company competency and compliance with QMS requirements.
• Facilitates the effective execution of Spacelabs Corrective and Preventive Action, including root cause identification, remedial planning, reporting, and completion of remedial action plans.
• Plan, perform, and document Internal Quality Audits.
• Participates and/or develops and monitors key performance indicators; recommends solutions and engages in continuous improvement activities.
• Develops and/or generates metrics to support management reporting requirements.
• Operate as a QMS Change Agent, planning, facilitating, completing, and documenting major company process changes and implementations (Process Change Orders).
• Creates and maintains required quality system documents and records, including summaries and management reports.
• May function as a subject matter expert for FDA and Notified Body external audits.
• Evaluates the effectiveness and efficiency of regulated processes throughout the organization and makes recommendations for improvement.
• Assists in preparation, performance, and follow up for Management Review meetings.
• Supports and/or facilitates quality system tool updates (plan, protocol, report).
• Processes, generates change orders; functions as a change analyst.
• Provides Agile User Training.
• Evaluates new device requests and/or updates that require Global Trade Identification Numbers (GTIN); assigns numbers, as required.
• Maintains regulatory GTIN databases, i.e. GUIDID (FDA), EUDAMED (EU), etc., as required for medical device maintenance.
• Supports and/or facilitates nonconforming material reports, including execution, evaluation, processing, and closure of nonconforming material report.
• Coordinates and/or conducts Material Review Board meetings and investigations.
• Supports and/or facilitates training programs and configuration in ComplianceWire.
• Supports and/or facilitates process deviations.
• Supports and/or generates quality system software requirements and validation protocols.
• Duties may be modified or assigned at any time to meet the needs of the business.
• Identifies, plan, pursues, and completes incoming and backlogged Quality Assurance and Quality Management System work activities.
• Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork.
• 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.
• Duties may be modified or assigned at any time to meet the needs of the business.

• Bachelor of Science in engineering, business, science, quality assurance, or related field, or equivalent professional experience.
• Medical Device Experience required.
• 5 years of experience working in quality, manufacturing, and/or engineering disciplines in the medical device industry.
• 5 years experience with CAPA, NMR, Quality System Process Management and Change Control; ISO 13485 Lead Auditor Certification.
• Ability to communicate effectively with staff at all levels of the organization.
• Ability to manage multiple, complex priorities within demanding timeframes. Strong project management skills.
• Highly developed relationship-building skills, and strong presentation and communication skills.
• Experienced user in Microsoft applications.

Preferred

• Familiarity with Agile, ComplianceWire, and/or CATSWeb.
• Understanding of statistical analysis and six sigma methodology.
• Experience operating under design control and Good Manufacturing Practices.
• Ability to manage activities and quality control initiatives through timelines to meet corporate goals.

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.

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