Job Description

Who we want

Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.

Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.

Insightful advisors. Managers who lead strategy development and provide guidance to teams.

Subject matter experts. Managers who not only oversee the collection, review, and analysis of data but can interpret, translate, and present on all various matters as needed.

What you will do

As a Senior Manager, Customer Quality Engineer, you will manage the activities of the Customer Quality Engineering teams, including all activities in support of post-market surveillance, support for commercial holds, complaint handling, post market risk assessment, product field action assessment, post-market design changes, NC/CAPA investigations, product performance trending and monitoring.

In this role you will collaborate with the service team in the activities required to maintain devices in a ready state for customers. You will be an advocate for the customer with field sales and service and will be the lead for responding to customer inquiries and escalations related to product issues experienced in the market.

* Direct the activities of the Customer Quality team, including all Post-Market support and surveillance activities through engagement with cross-functional partners.
* Works with the field service teams to establish processes that ensure a device is maintained in a safe and efficacious manner in the field.
* Own, establish and update/maintain written procedures associated to all Post-Market support and surveillance on an ongoing basis to ensure continued compliance with domestic and international regulatory requirements and governing corporate procedures.
* Monitor key performance indicators for Post-Market support and surveillance and report information to upper management as part of the ongoing management review process.
* Assess department needs and recruit and train personnel; set standards of performance; select, appraise, train, and coach team members to meet performance standards.
* Provide coordination between the customer quality and other areas of the company to facilitate investigation, corrective action, and resolution to product performance issues.
* Provide project, department, and company guidance based on current and emerging needs relating to the management of customer complaints and medical device reporting requirements.
* Leads the response to customer inquiries and escalations for product issues experienced by customers in the field. Partners on these responses with commercial and technical subject matter experts to ensure an outstanding customer experience.
* Define and manage budgets for assigned cost centers.

What you will need:

Basic Qualifications:

* Bachelors Degree is required.
* Minimum 10 years relevant working experience in a GMP manufacturing environment in Medical Device, Pharma, Automotive, Aerospace industry or similarly regulated environment with 5 years leadership/managerial experience.

Preferred Qualifications:

* Bachelors degree in a science or technical field strongly preferred.
* Extensive knowledge of Quality System Regulations (FDA, TUV), preferably with Class III medical devices, including interactions with external regulators.
* Self-motivated, able to manage a diverse team, able to accomplish multiple assignments simultaneously.
* Proven experience in achieving results through influence management and motivating teams; candidate must have a demonstrated ability to work constructively across all functions of the organization to drive successful outcomes.
* Strong team management and leadership skills. Ability to create and implement strategies, define and articulate clear role expectations and direction.
* Strong project management, organizational, and problem-solving skills.