Manager, Complaint Analyst

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee a team of high-performing Analysts by recruiting, selecting, onboarding, and fostering their professional development.

• Inspire and guide a high-achieving team by setting clear job expectations, creating action plans, evaluating and appraising work performance, and providing coaching and support to team members.

• Conduct regular check-ins and annual performance evaluations.

• Set and manage goals for direct reports, ensuring alignment with organizational objectives.

• Lead and participate in Propel Validations and necessary updates.

• Develop and revise complaint documentation and procedures.

• Onboard new team members on the proper complaint intake process, follow-ups, reviews, and resolutions.

• Educate team members on new procedures and processes.

• Suggest and execute improvements in complaint handling processes.

• Assess the accuracy of team members' complaints and communicate necessary adjustments.

• Act as the Subject Matter Expert (SME) for complaint intake during Quality team audits.

• Oversee complaint investigations, ensuring thoroughness and consistency in complaint records, and assist in preparing reports on complaint data, metrics, and trends.

⛳️ Requirements

• Education: Bachelor of Science in Engineering, Technical or Life Science discipline, or equivalent work experience is preferred.

• A minimum of 15 years of experience in the medical device industry is required.

• Work location: Remote (within California).

• Travel: Must be able to travel up to 10%, which may include overnight domestic and/or international travel.

• Proficient in FDA 21 CFR part 820.198 and part 803, ISO 13485, and related ISO/EN standards.

• Strategic thinker who is also hands-on when necessary, exhibiting a high level of energy and initiative to continuously pursue functional and process improvements.

• Open and straightforward communication style with a commitment to continuous improvement and excellence.

• Experience with Class II and/or III sterile devices is preferred.

• Exceptional verbal and written communication skills, with a proven ability to convey information clearly and professionally.

• Must comply with all relevant county, state, and federal regulations regarding vaccinations.

🏝️ Benefits

• Competitive base salary ranging from $145,000 to $155,000.

• Stock options that provide ownership and a stake in a mission-driven organization.

• Comprehensive employee benefits package, including 401(k), healthcare insurance, and paid vacation.