- 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).
- 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.
- 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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Senior Manager, Complaint Investigation - Memphis, United States - Olympus
Description
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
Job Qualifications
Required:
Preferred: