Manager, Post Market Engineering

iRhythm Technologies, Inc. • FL

127d • $112,000 - $145,000

About The Position

iRhythm Technologies, Inc. is looking for a Manager, Post Market Engineering to join the Quality team. The Post Market Engineering Manager will oversee the Post Market Quality Engineering team to ensure compliance, accuracy, and efficiency, including oversight over a Complaints Lab. The position will also provide data and analysis to support Quality department as needed.

Requirements

• Bachelor’s Degree or Associate Degree in science, technology or medical fields.
• 8+ years of experience in Quality Assurance and/or a complaint processing role, experience with Medical Device Reporting.
• Supervisory or Manager experience in a medical device company.
• Strong working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD/MDR.
• Strong interpersonal and organizational skills to enable working cross-functionally within the organization.
• Strong problem-solving skills, critical-thinker, and experience at investigating and resolving complex issues.
• Understand basic principles of good technical writing skills and be able to articulate findings and formulate conclusions.
• Identify problems and lead projects to improve processes, procedures and/or practices; recommend and resolve solutions.
• Excellent communication (verbal and written) and interpersonal skills required.
• Demonstrated experience with MS Word, Excel, Adobe Acrobat, and other commonly used software systems.
• Must be able to work under minimum supervision and in a team environment.

Responsibilities

• Provide supervision and leadership to a team of Quality Engineers and Complaints Technicians.
• Manage and balance assignment of work to team to meet goals.
• Provide guidance, development and performance feedback and opportunities for growth through regular one-one-one and team meetings.
• Conduct annual performance reviews with quarterly check-ins.
• Establish and maintain documented laboratory procedures.
• Manage and update testing methods, techniques and equipment, as needed.
• Review investigated complaints to ensure procedural and regulatory compliance.
• Ensure complaints are closed in a timely manner and all global medical device reports are submitted within regulatory timeframes.
• Manage projects associated with the Complaint Handling process.
• Participate in process improvements to improve compliance, effectivity, and efficiency, and take ownership for updating procedures and policies.
• Perform other quality and regulatory-related duties as assigned.

Benefits

• Inclusive workforce culture.
• Opportunities for career growth and development.
• Work-life balance with flexible working options.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees