Overview

The Quality Systems Manager is responsible for managing all facets of quality assurance, including ownership of the Quality Management System (QMS) for the company. The primary focus is to ensure that the QMS and all aspects of quality assurance activities are compliant with U.S. FDA, ISO, and MDR Standards and Regulations for Medical Devices. The Quality Systems Manager manages quality system administration, internal audits, corrective action, and preventive action (CARs and PARs), operational change control, quality system software validations, and the quality system training program.

Responsibilities

• Establish and manage the maintenance of the Spacelabs Quality Management System.
• Establish and maintain quality programs and subsystems to support corporate quality policy, regulatory requirements, and quality objectives.
• Manage control of Quality Management System changes.
• Manage the document control process.
• Ensure staff training and competency to ensure adequate and effective QMS performance.
• Facilitate company operational change control systems: Corrective Action, Preventive Action, Process Change Control, and Exception Handling.
• Create and update quality system procedures to achieve continuous compliance with the FDA Quality System Regulation, ISO13485, European MDR, MDSAP, and Canadian regulatory requirements.
• Ensure and support assessment of QMS performance with key performance indicators and quantifiable quality improvement objectives.
• Manage internal audits of policies, procedures, and company activities to ensure compliance with regulations, standards, and Spacelabs QMS.
• Support external audits and communications with foreign regulatory sponsors for global regulatory approvals.
• Build a high-performance team through recruiting, mentoring, leading, and assisting team members with career and performance development.
• Establish group goals and objectives as well as cross-functional goals and objectives; ensure progress towards goals.
• Ensure timely and effective validation of QMS Software (Computer System Validation).
• Demonstrate 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.
• Hire, manage, evaluate, and develop a team of employees to meet functional deliverables and responsibilities. Completes the company's people management requirements. Exhibits the manager's core competencies.
• 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 Spacelabs Healthcare 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 business, sciences, quality management, related field, or additional equivalent professional experience.
• 10+ years of Quality Assurance experience in a regulated environment.
• 5+ years in medical devices.
• 4+ years of supervisory experience.
• Expert knowledge of FDA regulation, EU MDR, ISO 13485, and related regulations and standards.
• Experience with Agile, ComplianceWire, Catsweb, and/or similar applications.
• ASQ CQA, CQE, and/or CQM certifications are highly desired.
• Ability to manage multiple, complex priorities within demanding timeframes. Strong project management skills.
• Highly developed relationship-building skills and strong presentation and communication skills.
• Proven ability to deliver results through others, both direct and matrixed. Proven ability to lead, develop, motivate, and hold others accountable.
• Experienced user in Microsoft applications required.
• Up to 5% of domestic and international travel is required. Must be able to acquire all necessary travel documents.

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Please review our benefits here: Life at OSI

Pay may range between $150,000.00 - $175,000.00 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 a 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.

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.