Executive Director, Complaints at Olympus Corporation of the Americas in Tennessee, IL
Are you looking for a company that cares about people's lives and health, including yours? At Olympus, we help make people's lives healthier, safer and more fulfilling, every day. Let's inspire healthier lives, together. Job Description Establish and manage a Global Complaint Center of Excellence overseeing governance of ETQ and the complaint process (OGBR-M), Global Complaint Training, Global Trending and Signal Detection, Global Complaint Management/Auditing, and Global Adverse Event Reporting. Group will eventually be approximately 60 HC. Job Duties Leads and directs Global Complaint Center of Excellence team members Manages the development and performance of staff. Ability to assess and develop team talent to support business objects and personal objects of employees. Prioritize resources based on the strategic objectives of the organization. Establishes the department's objectives (MBO) to meet Quality Objectives, organization's goals and strategic plan. Provides leadership in establishing processes or systems to support ETQ. Establish and manage the global complaint process and ETQ, oversee the change process, manage the OGBR-M, convert Risk Summary Sheet to automation format in ETQ or other automation, provide oversight of training that supports the Global Complaint process, perform regular data analysis to identify safety and compliance signals in the complaint process, manage the Quality Assurance Agreements between Olympus entities as they relate to the complaint process as well as oversee the compliance to those agreements. Manage the Global Adverse Event Reporting function for all of Olympus. Job Requirements REQUIRED
Qualifications:
Bachelor of Science, MBA Preferred Minimum of 10 years Regulated Quality Experience, Medical Device Experience preferred Minimum of 7 years Experience managing people , ideally across multiple locations, sites, countries Minimum of 7 years combined Experience working in Quality Systems, Document Control and Training Minimum of 7 years Experience managing the business aspects of quality and regulatory projects Travel up to 20% of the time, availability to take evening and early morning teleconferences PREFERRED
Qualifications:
Ability to influence outside of direct control at Sr. And International CQE and/or Six Sigma Black Belt Certification preferred. Comprehensive understanding of principles and concepts of Process Excellence, Statistical Process Control and Applied Statistics preferred. Ability to handle multiple projects simultaneously and to discern major quality issues. Change agent to break down barriers, to prepare, and influence direct team, other functions and OCA sites to new ideas and ways to execute Quality Systems sub-systems to improve Olympus compliance profile Thorough knowledge of 21 CFR 820 and ISO 13485 required. Working knowledge of international medical device quality system requirements required. Demonstrated success in the design and deployment of innovative quality systems.
Salary Range:
$200K -- $250K
Minimum Qualification
Auditing & ComplianceEstimated Salary: $20 to $28 per hour based on qualifications.
Qualifications:
Bachelor of Science, MBA Preferred Minimum of 10 years Regulated Quality Experience, Medical Device Experience preferred Minimum of 7 years Experience managing people , ideally across multiple locations, sites, countries Minimum of 7 years combined Experience working in Quality Systems, Document Control and Training Minimum of 7 years Experience managing the business aspects of quality and regulatory projects Travel up to 20% of the time, availability to take evening and early morning teleconferences PREFERRED
Qualifications:
Ability to influence outside of direct control at Sr. And International CQE and/or Six Sigma Black Belt Certification preferred. Comprehensive understanding of principles and concepts of Process Excellence, Statistical Process Control and Applied Statistics preferred. Ability to handle multiple projects simultaneously and to discern major quality issues. Change agent to break down barriers, to prepare, and influence direct team, other functions and OCA sites to new ideas and ways to execute Quality Systems sub-systems to improve Olympus compliance profile Thorough knowledge of 21 CFR 820 and ISO 13485 required. Working knowledge of international medical device quality system requirements required. Demonstrated success in the design and deployment of innovative quality systems.
Salary Range:
$200K -- $250K
Minimum Qualification
Auditing & ComplianceEstimated Salary: $20 to $28 per hour based on qualifications.
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