Overview
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 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 Quality Assurance Manager manages quality system processes, internal audits, corrective action preventive action (CARs and PARs), change control, quality system software validations and the quality system training program. These activities include ensuring compliance to applicable standards and regulations associated with these functional areas, process development and maintenance, and employee development and management.
Responsibilities
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Drive improvement of Key Performance Indicators (KPI’s) related to the department and company quality objectives.
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Establishes and maintains quality programs and systems to support corporate quality policy, regulatory requirements, and quality objectives.
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Manage the quality management system for our medical device products and maintain its effectiveness and improvements in eQMS systems.
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Provide QMS support and guidance for new products and product maintenance.
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Create and update quality system procedure to achieve continuous compliance to FDA QSR, ISO13485, European MDD, MDSAP and Canadian regulatory requirements.
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Assures the quality assurance programs and policies are maintained and modified regularly to meet global company growth plan.
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Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
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Support external audits and supports communication with foreign regulatory sponsors for global regulatory approvals.
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Functions as the Spacelabs Device Master Record owner.
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Establishes and maintains Corrective Action and Preventive Action management systems to ensure that all CAPA’s are assigned.
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Ensure timely and effective maintenance of the Corrective Actions and Preventive Actions including CAPA logs.
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Ensure substantial Quality Assurance employee ownership and completion of CAPA activities.
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Manages conformity assessment audits of policies, procedures and quality systems to identify non-conformities and ensure prompt and effective corrective actions are accomplished.
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Establishes and maintains the management of the Internal Quality Audit (IQA) system.
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Establishes and maintains a dashboard of current status.
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Develop a team of Internal Quality Auditors across the RA/QA organization.
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Audit checklists are produced.
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Review of audit reports prior to Issue.
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Review and approval of corrective actions prior to closure.
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Facilitate basic IQA training of all audit staff, including Checklist preparation, documenting findings, final audit reporting, change order validation, and audit corrective action.
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Team leader who supports a high performing culture with mixed onsite, hybrid and remote team members supporting the global QMS system.
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Builds a high-performance team through recruiting, mentoring, leading, and assisting team members with career and performance development.
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Establishes group goals and objectives as well as cross-functional goals and objectives; ensures progress towards goals is met.
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Manages Spacelabs configuration control system and change control processes.
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Manages quality system computerized software validation(CSV).
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Establishes and maintains a CSV process.
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Validation a gap list of QMS software that has not been validated.
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Ensure timely and effective validation of QMS Software.
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Manages Spacelabs quality system training program and application.
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Manages conformity assessment audits of policies, procedures and quality systems to identify non-conformities and ensure prompt and effective corrective actions are accomplished.
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Functions as the Spacelabs Subject Matter Expert for quality system processes, Change control program, Training program, quality system software validations.
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Makes risk-based decisions as required to support corporate policies.
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Upholds the Company’s core values of Integrity, Innovation, Accountability, and Teamwork.
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Demonstrates behavior consistent with the Company’s Code of Ethics and Conduct.
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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.
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Manages, evaluates and develops a team of employees to meet functional deliverables and responsibilities. Completes company people management requirements. Exhibits manager core competencies.
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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.
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Duties may be modified or assigned at any time to meet the needs of the business.
Qualifications
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Bachelor’s degree in business, sciences, quality management, or related field required.
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12+ years of Quality Assurance experience in a highly regulated environment.
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5+ years in medical device manufacturing.
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5+ years’ experience managing a team.
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Experience with FDA, MDR, MDSAP, ISO 13485, ISO 14971, EN 62304, Cybersecurity, IEC 60601-1.
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Proficiency in Microsoft applications required.
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Ability to manage multiple, complex priorities within demanding timeframes. Strong project management skills.
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Highly developed relationship-building skills, and strong presentation and communication skills.
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Proven ability to deliver results through others, both direct and matrixed. Proven ability
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to lead, develop, motivate and hold others accountable.
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Familiarity with Agile, ComplianceWire, Catsweb, MasterControl preferred.
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Up to 5% of domestic and international travel is required. Must be able to acquire all necessary travel documents.
#LI-Hybrid
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Pay may range between $165,000.00 - 185,000.00 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.
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.
