Quality Assurance Manager at Osi Systems in Snoqualmie, WA
The Quality Assurance Manager manages quality system processes, internal audits, corrective action preventive action (CAPA), change control, nonconforming material reports, quality system software validations, the unique device identifier program 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 Team leader that supports a high performing culture with mixed onsite, hybrid and remote team members supporting the global QMS system. Builds a high-performance team through recruiting, mentoring, leading, and assisting team members with career and performance development. Establishes group goals and objectives as well as cross-functional goals and objectives; ensures progress towards goals is met. Responsibility to drive improvement of Key Performance Indicators (KPI's) related to the department and company quality objectives. Establishes and maintains quality programs and systems to support corporate quality policy, regulatory requirements, and quality objectives. Manage the quality management system for our medical device products and maintain its effectiveness and improvements in eQMS systems Provide QMS support and guidance for new products and product maintenance. Create and update quality system procedure to achieve continuous compliance to FDA QSR, ISO13485, European MDD, MDSAP and Canadian regulatory requirements Assures the quality assurance programs and policies are maintained and modified regularly to meet global company growth plan. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. Support external audits and supports communication with foreign regulatory sponsors for global regulatory approvals Manages Spacelabs configuration control system. Manages Spacelabs change control processes. Functions as the Spacelabs Device Master Record owner. Manages quality system software validation. Manages Spacelabs Unique Device Identifier (UDI) program. Manages Spacelabs quality system training program and application. Manages conformity assessment audits of policies, procedures and quality systems to identify non-conformities and ensure prompt and effective corrective actions are accomplished. Functions as the Spacelabs Subject Matter Expert for quality system processes, Change control program, Training program, UDI program, quality system software validations. Upholds the Company's core values of Integrity, Innovation, Accountability, and Teamwork. Demonstrates 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. Manages, evaluates and develops a team of employees to meet functional deliverables and responsibilities. Completes company people management requirements. Exhibits manager core competencies. 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 or related field, or equivalent professional experience. 6
years of Quality Assurance experience in a regulated manufacturing environment, with at least 5 years in medical device manufacturing. 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. Familiarity with Agile, ComplianceWire, Catsweb, MasterControl preferred. Up to 5% domestic and international travel required. Must be able to acquire all necessary travel documents. Company COVID-19 Vaccine Policy To comply with applicable government requirements, all U.S. employees must be fully vaccinated against COVID-19 unless they are entitled to and approved for a legal accommodation, in accordance with the Company's COVID-19 Vaccination Policy.
Salary Range:
$200K -- $250K
Minimum Qualification
Quality Assurance, Technology ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
ensuring compliance to applicable standards and regulations associated with these functional areas, process development and maintenance, and employee development and management. Responsibilities Team leader that supports a high performing culture with mixed onsite, hybrid and remote team members supporting the global QMS system. Builds a high-performance team through recruiting, mentoring, leading, and assisting team members with career and performance development. Establishes group goals and objectives as well as cross-functional goals and objectives; ensures progress towards goals is met. Responsibility to drive improvement of Key Performance Indicators (KPI's) related to the department and company quality objectives. Establishes and maintains quality programs and systems to support corporate quality policy, regulatory requirements, and quality objectives. Manage the quality management system for our medical device products and maintain its effectiveness and improvements in eQMS systems Provide QMS support and guidance for new products and product maintenance. Create and update quality system procedure to achieve continuous compliance to FDA QSR, ISO13485, European MDD, MDSAP and Canadian regulatory requirements Assures the quality assurance programs and policies are maintained and modified regularly to meet global company growth plan. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. Support external audits and supports communication with foreign regulatory sponsors for global regulatory approvals Manages Spacelabs configuration control system. Manages Spacelabs change control processes. Functions as the Spacelabs Device Master Record owner. Manages quality system software validation. Manages Spacelabs Unique Device Identifier (UDI) program. Manages Spacelabs quality system training program and application. Manages conformity assessment audits of policies, procedures and quality systems to identify non-conformities and ensure prompt and effective corrective actions are accomplished. Functions as the Spacelabs Subject Matter Expert for quality system processes, Change control program, Training program, UDI program, quality system software validations. Upholds the Company's core values of Integrity, Innovation, Accountability, and Teamwork. Demonstrates 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. Manages, evaluates and develops a team of employees to meet functional deliverables and responsibilities. Completes company people management requirements. Exhibits manager core competencies. 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 or related field, or equivalent professional experience. 6
years of Quality Assurance experience in a regulated manufacturing environment, with at least 5 years in medical device manufacturing. 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. Familiarity with Agile, ComplianceWire, Catsweb, MasterControl preferred. Up to 5% domestic and international travel required. Must be able to acquire all necessary travel documents. Company COVID-19 Vaccine Policy To comply with applicable government requirements, all U.S. employees must be fully vaccinated against COVID-19 unless they are entitled to and approved for a legal accommodation, in accordance with the Company's COVID-19 Vaccination Policy.
Salary Range:
$200K -- $250K
Minimum Qualification
Quality Assurance, Technology ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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