Job Description

This management position will be responsible for 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 engineers and technicians to drive business process excellence and regulatory compliance.

Job Duties

• Provide direction to individuals who investigate complaints, perform data analysis, and manage metrics.

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  Supervise and coach a team of engineers and technicians to achieve team metrics, department objectives and organizational goals.

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  Provide guidance and training to staff, assist them in attaining career goals, motivate individuals to achieve results, and recruit and maintain a high-quality staff.

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  Oversee Complaint Investigation process and drive continues improvement efforts.

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  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.

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  Review data analysis to detect emerging trends of such issues that may require action and escalation to Senior Leadership.

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  Influence Sr. Leadership on potential improvements or enhancements to the quality system and processes.

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  Maintain and enhance cross-functional team relationships within the legal manufacturers, and distribution centers across the entire Olympus network.

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  Serves as Subject Matter Expert (SME) for all internal and external audits for complaint investigation process.

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  Coach sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

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  Lead team and projects to successful conclusions while achieving strategic milestones.

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  Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

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  Develop future leaders through partnerships and mentoring.

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  Monitor compliance with company policies and procedures (e.g. compliance with FDA, ISO, MDR regulations)

Job Requirements

REQUIRED QUALIFICATIONS:

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  Bachelor’s degree in an engineering discipline, data science, or STEM discipline.

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  Minimum of 5 years of experience in Post Market, Design Assurance, Quality Engineering, or equivalent

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  Minimum of 2 years of experience supervising people.

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  Occasional Travel Required for meetings and projects, and to periodically meet with employees in other part of the country.

PREFERRED QUALIFICATIONS:

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  Passionate about leading people to bring out their best

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  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)

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  Strong communicator (written and verbal) who can effectively communicate up, down, and across a global organization.

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  Proven mindset of proactive continuous improvement

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  The anticipated compensation range for this position is 106,820.00 USD to 149,548.00 USD annually and the compensation offered will depend on the candidate’s qualifications.