Job Description
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!
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 Senior Complaint Analyst is responsible for executing and maintaining the Spacelabs Healthcare Complaint Handling and Adverse Event reporting process. This role works in a fast-paced environment to analyze customer complaints to determine which are regulatory-reportable and coordinates activities with internal, field, and end-use customers.
This is a high-impact role that ensures the efficient and timely review of customer complaints, enabling a quick understanding of the performance of Spacelabs products. The individual will ensure compliant and effective execution of all quality processes while meeting regulatory and industry standards in accordance with Spacelabs Healthcare’s requirements and expectations.
***This is a hybrid position that requires onsite collaboration at the Spacelabs facility in Snoqualmie, WA three or more days per week, dependent on business needs.***
Responsibilities
- Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
- Apply knowledge, as related to product application, to evaluate identified complaints. Investigate complaints by gathering sufficient data from customers/users, clinical staff, field representatives, and internal employees.
- Establish regulatory reportability decisions using event investigation and regulatory decision models.
- Participate in the development and modification of these decision models with changes in product improvements
- Leads the end-to-end investigation of complaints, including condensing pertinent information, analyzing findings, and presenting a concise overview of the inquiry process, including key issues identified, evidence gathered, and resolutions proposed or implemented to uphold consistent compliance with government-mandated regulations.
- Works under general supervision and established processes and operational policies with independent judgement, investigates and assists in resolving highly complex complaints by monitoring product analysis findings or service analysis notes, and ensures the implementation of solutions to address customer concerns efficiently.
- Write Medical Device Reports (MDRs) and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
- Apply codes to events to facilitate product performance tracking. Review coding and investigations with engineering, clinical, and other internal staff.
- Compose written communications detailing the complaint/observation, investigation, and/or product analysis, and corrective actions, as applicable. These communications may be used internally or externally based on the event(s).
- 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.
Qualifications
- Bachelor’s degree in engineering, Regulatory Affairs, or related or equivalent experience.
- 7+ years of complaint handling and adverse event submissions in a medical device company.
- Applied experience and knowledge of ISO 13485 (Quality Management Systems), FDA medical device regulations, and Risk Management (ISO 14971) to instill a culture dedicated to ensuring patient safety and sustained regulatory compliance.
- Additional applied knowledge of international standards and regulations is preferred.
- Proficiency in data analysis, trending tools, and KPI/dashboard development.
- Must be able to perform critical thinking to identify and synthesize patterns from emerging trends and translate them into actionable recommendations.
- Strong technical, written, and verbal communication skills; ability to work effectively across all levels of a global organization and remain composed in urgent circumstances.
- Must have the ability to work in collaborative and independent work situations and environments with minimal supervision.
- Proficiency in multi-tasking and working in a high-paced, matrixed environment with an awareness of continued impact on compliance and operational performance.
- Ability to lead and influence cross-functional teams, including Procurement / Supply Chain, Regulatory Affairs, Service, and Research & Development, to drive reduction in patient safety risk and greater levels of regulatory compliance.
- Ability to learn how to use the Spacelabs Healthcare products that are supported (training provided)
- Organized and resourceful with excellent attention to detail and ability to execute on assigned project plans.
#LI-hybrid
#LI-TC1
Please review our benefits here: Life at OSI
Pay may range between $100,000 - $130,000 annually.
The pay range above represents annual base salary only. Final compensation will be determined based on factors such as your job level, geographic location, date of hire, experience, job-related knowledge and skills, and education in conjunction with market and business considerations.
Base salary is one component of your total rewards package. You may be eligible for long-term incentives, potential discretionary bonuses, and the ability to purchase company stock at a discounted rate through the Employee Stock Purchase Program (ESPP). OSI also offers comprehensive benefits including various options for health plans, access to 401(k) retirement plan, health savings account, disability insurance, life insurance, AD&D insurance, leave of absence programs and an array of voluntary benefits. In addition, paid time off is offered to be used for vacation, holidays, bereavement, and jury duty. Full-Time salaried employees are entitled to flexible time-off.
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 Veteran
Know Your Rights
Poster Link:
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.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.
- Bachelor’s degree in engineering, Regulatory Affairs, or related or equivalent experience.
- 7+ years of complaint handling and adverse event submissions in a medical device company.
- Applied experience and knowledge of ISO 13485 (Quality Management Systems), FDA medical device regulations, and Risk Management (ISO 14971) to instill a culture dedicated to ensuring patient safety and sustained regulatory compliance.
- Additional applied knowledge of international standards and regulations is preferred.
- Proficiency in data analysis, trending tools, and KPI/dashboard development.
- Must be able to perform critical thinking to identify and synthesize patterns from emerging trends and translate them into actionable recommendations.
- Strong technical, written, and verbal communication skills; ability to work effectively across all levels of a global organization and remain composed in urgent circumstances.
- Must have the ability to work in collaborative and independent work situations and environments with minimal supervision.
- Proficiency in multi-tasking and working in a high-paced, matrixed environment with an awareness of continued impact on compliance and operational performance.
- Ability to lead and influence cross-functional teams, including Procurement / Supply Chain, Regulatory Affairs, Service, and Research & Development, to drive reduction in patient safety risk and greater levels of regulatory compliance.
- Ability to learn how to use the Spacelabs Healthcare products that are supported (training provided)
- Organized and resourceful with excellent attention to detail and ability to execute on assigned project plans.
#LI-hybrid
#LI-TC1
Please review our benefits here: Life at OSI
Pay may range between $100,000 - $130,000 annually.
The pay range above represents annual base salary only. Final compensation will be determined based on factors such as your job level, geographic location, date of hire, experience, job-related knowledge and skills, and education in conjunction with market and business considerations.
Base salary is one component of your total rewards package. You may be eligible for long-term incentives, potential discretionary bonuses, and the ability to purchase company stock at a discounted rate through the Employee Stock Purchase Program (ESPP). OSI also offers comprehensive benefits including various options for health plans, access to 401(k) retirement plan, health savings account, disability insurance, life insurance, AD&D insurance, leave of absence programs and an array of voluntary benefits. In addition, paid time off is offered to be used for vacation, holidays, bereavement, and jury duty. Full-Time salaried employees are entitled to flexible time-off.
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