Sr. Director Global Quality

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 plays an integral role in improving treatment and helping providers deliver exceptional care to their patients. From newborns to centenarians, more than 60 million people benefit each year 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.

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

The Senior Director of Global Quality is responsible for worldwide medical device quality engineering, quality assurance, and quality control for Spacelabs products and services. This position ensures that company products, operations, and outputs comply with all applicable medical device standards and regulations.

The Senior Director of Global Quality makes certain that all company plans, personnel, and process ensure a Quality First philosophy, ensuring that all procedures and controls accomplish intended objectives: Safe and effective products, ecstatic and loyal customers, simple and effective operations, and successful and profitable business.

The Senior Director of Global Quality leads the company's three quality functions: Quality Engineering, Quality Assurance, and Quality Control. This position responsible for the establishment and effective and intended performance of the Spacelabs Quality Management System.

This position is located at Spacelabs' headquarters in Snoqualmie, Washington

Quality Engineering

Quality support for the company's design control, manufacturing, and service functions:

• Design Control
• Risk Management
• Technical Documentation
• Finance Acceptance and Design Transfer
• Labeling Controls (Product Labeling, Product Labels, and Promotional Labeling)
• Manufacturing engineering support
• Servicing activities
• Supplier Quality
• Supplier Audits and Corrective Action

Quality Assurance

Establishment and maintenance of the company's Quality Management System(s).

This position is responsible for leading and executing the global quality strategy for all business areas. Responsibilities include managing the planning and implementation of the company quality system; creation and implementation of corporate processes, process maps, procedures, and tools; management of internal and external audits; management of global document control activities; and the management and implementation of corporate quality tools.

Critical Quality Functions

• Quality Policy
• Quality Manual(s)
• Quality Procedures, Work Instructions, and Templates
• Management Review
• Management Responsibility
• Document and Record Controls
• Internal Quality Audits
• Corrective and Preventive Action
• Computer System Validation
• Quality System Change Control

Quality Control

Quality Control maintains company quality standards by approving incoming materials, in-process production, finished products, and recording the results.

• Receiving Inspection
• Nonconforming Materials assessment and reporting
• Material Review Board
• Inventory Management
• Calibration
• Maintaining QC record

Routine Responsibilities

• Managing and maintaining Spacelabs quality programs and systems to support corporate quality policy, regulatory requirements, quality objectives and quality manual
• Developing capital, operating, staffing, and project budgets; establishing annual department operating objectives and plans; and making staffing and compensation decisions
• Ensuring that Quality professionals are fully competent for their roles, that they are effectively organized to deliver service to users, and that they receive appropriate training and mentoring
• Driving Continual Improvement to routinely achieve more effective and efficient operations
• Management of the company's data driven management system, including Key Performance Indictors (KPI), Quantifiable Quality Objectives (QQO's), and other Quality objectives
• Capture of Voice of the Customer feedback.
• 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.
• 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.
• Duties may be modified or assigned at any time to meet the needs of the business.

• Bachelor's degree in Engineering, Business, Quality Assurance, or related field.
• 12+ years medical device quality leadership experience with a demonstrated ability to lead and manage people and teams.
• 5+ years' experience working with Manufacturing and Engineering.
• 8+ years' experience as a global manager across multiple geographic regions and time zones.
• 5 + years' experience with medical device software experience required.
• 3 + years' experience working with OEM vendors required.
• Software as a Medical Device experience, preferred.
• Demonstrated knowledge of FDA, ISO, MDD, MDR, TGA and Health Canada medical device requirements
• Creative problem solving, flexibility, and good negotiation skills.
• Proven ability to drive results to established timelines and on budget.
• Proven ability to communicate effectively both in writing and verbally with staff at all levels of the organization.
• Proficiency with Microsoft software applications.
• International travel will be required up to 10%.
• Strong interpersonal skills, excellent formal and informal communication skills, innovative problem-solving skills and strong facilitation skills are required.
• Candidate must be performance and results oriented and be able to develop, motivate and lead strong, effective, teams.
• Ability to work well under quick changing priorities and with ambiguity.

#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.

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

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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.