Senior Manager, Complaint Investigation
4 weeks ago
Job Description
This management position will be responsible for the Regional Investigation Center, and the Complaint Investigation handling, including but not limited to: complaint trending, complaint product analysis, quality escalation decisions and complaint investigations. You will lead a team of managers and principal engineers to drive business process excellence and regulatory compliance.
Job Duties
Provide direction to individuals who investigate complaints, perform data analysis, and manage metrics. Supervise and coach a team of managers and engineers to achieve team metrics, department objectives and organizational goals. Provide guidance to staff, assist them in attaining career goals, motivate individuals to achieve results, and recruit and maintain a high-quality staff. Oversee Complaint Investigation process and partner with the Global Complaints Center of Excellence to drive continues improvement efforts. Analyze and provide complaint data reports for Quarterly Management Review (QMR), Clinical Experience Report (CER), Periodic Safety Update Report (PSUR), Regulatory Additional Information requests, among others. Review data analysis to detect emerging trends of such issues that may require action and escalation to Senior Leadership. Influence Sr. Leadership on potential improvements or enhancements to the quality system and processes. Maintain and enhance cross-functional team relationships within the Regional Complaint Handling Center, MDR/Vigilance teams, Medical Safety, Design Assurance, and legal manufacturers, across the entire Olympus network. Coach sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Lead team and projects to successful conclusions while achieving strategic milestones. Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Develop future leaders through partnerships and mentoring. Monitor compliance with company policies and procedures (e.g. compliance with FDA, ISO, MDR regulations).Job Qualifications
Required:
Bachelor’s degree in an engineering discipline, data science, or STEM discipline. Minimum of 7 years of experience in Post Market, Design Assurance, Quality Engineering, or equivalent. Minimum of 5 years of experience supervising people. Occasional Travel Required for meetings and projects, and to periodically meet with employees in other part of the country.Preferred:
Passionate about leading people to bring out their best. Proven ability to get the day-to-day tasks completed efficiently to make time for individuals to develop professionally and personally, and to engage in projects that drive their passion(s). Strong communicator (written and verbal) who can effectively communicate up, down, and across a global organization. Proven mindset of proactive continuous improvement. Why join Olympus? Here, people matter—our health, our happiness, and our lives. Competitive salaries, annual bonus and 401(k)* with company match Comprehensive Medical, Dental, Visions coverage effective on start date 24/7 Employee Assistance Program Free virtual live and on-demand wellness classes Work-life balance supportive culture with hybrid and remote roles 12 Paid Holidays Educational Assistance Parental Leave and Adoption Assistance Volunteering and charitable donation match programs Diversity & Inclusion Programs including Colleague Affinity Networks On-Site Child Daycare, Café, Fitness Center** *US Only **Limited locations-
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