Job Description

Who we want

Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes finding ways to simplify, standardize and automate.

Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

Curious Learners. People who seek out cutting-edge research and information to expand and enhance their ability to be ready for whats next.

Collaborative partners. People who build and leverage cross-functional relationships to together ideas, data and insights to drive continuous improvement

What you will do

As a Lab Supervisor, Post Market Quality, you will ensure the complaint handling team achieves its objectives related to the handling and processing of product complaint investigations while meeting internal, FDA, ISO13485 and other regulatory requirements. Provide functional and project leadership to technicians in the planning and testing of potential new processes & devices.

Essential Duties and Responsibilities

* Provide leadership, management, and oversight to the Post-Market laboratory technician teams.
* May be designated the Division Process Owner for Complaints.
* Ensure complaint investigation team is performing thorough and timely complaint investigations.
* In collaboration with R&D & PMO stakeholders, ensure relevant R&D project activities are identified, defined and executed by technicians supporting R&D functions.
* Conduct personnel performance management functions including performance reviews, development, training needs identification, coaching and disciplinary actions.
* Establish and maintain an engaging, results oriented, safe, and positive work environment.
* Ensure an efficient output through the use of lean, 5S, visual work cues, and other workflow management methods.
* Monitor, manage, and take action to achieve complaint investigation metrics.
* Monitor, manage, and take action to ensure R&D projects are supported in accordance with the PMO timelines.
* Work with both internal and external customers to generate/analyze input/outputs generated from the Post-Market laboratory teams including, but not limited to, complaint information, R&D project support activities etc.
* Provide guidance to staff on complex investigations & projects.
* Ensure team produces reports with respect to customer complaint analysis, technical reports and maintain QMS documentation in accordance with applicable regulations.
* Potential to lead conference calls with the Sales Force on escalated complaint issues and may travel to customer sites as needed to support the field in resolution to complex product issues.
* Produce and review periodic trends analyses of complaint data to monitor device performance.
* Assists in supporting regulatory inspections. (FDA, ISO etc)
* Act as a liaison to Post-Market Quality Engineering Manager, Post-Market Quality Engineers, R&D project leads, Project Managers and R&D Management.
* Supports the Post-Market Surveillance Manager as needed.
* Coordinate accurate expense reporting allocation for the respective technician teams in collaboration with key stakeholders (Finance, Post-Market Surveillance, R&D).
* Routine management of laboratory budgets within provided projections; communicate areas of budget concerns to Post-Market Surveillance Manager in a timely manner.
* Supervise 6 direct reports.
* Other duties as assigned.

What you will need:

Basic Qualifications:

* Associates Degree with 5 years relevant working experience.
* Bachelors Degree with 2 years relevant working experience.

Preferred Qualifications:

* Bachelor's Degree (B.S) in an engineering discipline preferred.
* 2+ years relevant work experience preferred.
* Experience in medical device industry preferred.
* 1-3 years supervisory or leadership experience within a regulated industry preferred.
* FDA/ISO knowledge and experience preferred.
* Strong working knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook).
* Business Objects knowledge desired.
* Experience with statistical software packages such as Minitab or JMP is desired.
* Excellent documentation skills and attention to detail.
* Excellent analytical, interpersonal, verbal and written communication skills.
* Ability to work in a dynamic environment, both working in a team and independent capacity.
* Solid judgment and problem-solving skills.
* Ability to work cross functionally.
* Strong background in data analytics and trending preferred.
* Strong ability to coach and mentor staff.

Work Environment

* Lab and office environment.
* While performing the duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel objects; reach with hands and arms; balance; stoop, kneel, or crouch; talk or hear.
* The employee must occasionally lift and/or move up to 50 pounds.
* The noise level in the work environment is usually moderate.
* May be exposed to Hazardous materials. Employees need to consult MSDS in their work area.
* Required to wear Personal Protective Equipment to protect against exposure to Bloodborne Pathogens and chemicals when in the lab or appropriate.
* Up to 10% travel may be required.