Senior Manufacturing Quality Engineer

Job Summary:

This Pilot Operations Sr Quality Engineer role starts with the opportunity to partner on the development of delivery systems for the Transcatheter Heart Valve (THV) Business Unit as a part of clients Global Supply Chain. This cross functional partner will (1) interact with various functional departments to accomplish compliance and implementation of quality goals with a primary focus on quality operations for Pilot manufacturing, (2) work with THV new product development teams in the manufacturing of products for feasibility studies, quality system test samples, Early Human Use, and clinical studies and (3) support product transfer from Pilot manufacturing to receiving site manufacturing facilities.

Key Responsibilities:

• Work with new product development teams to help them efficiently navigate the Clients' Quality System in order to build quality system test samples and human use product according to project schedules

• Identify and ensure implementation of opportunities to optimize/improve manufacturing and inspection processes

• Perform risk assessment on early-stage product manufacturing processes (e.g., PFMEAs, Live Manufacturing Process Reviews)

• Analyze and resolve complex manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations)

• Develop/drive improvements for inspection test methods

• Lead test method validation activities for in-process inspections

• Facilitate and oversee Material Review Board to disposition potentially non-conforming human use products

• Track product yields and defect rates. Use data to report metrics at Quality Data Reviews and drive process improvements

Education and Experience:

• Prior experience in medical device manufacturing or operations preferred

• Experience with computerized Manufacturing Execution System (MES) preferred

• Bachelor's Degree in relative Engineering field plus minimum of four (4) years medical device industry experience required

• Master's Degree in relative Engineering field plus minimum of three (3) years medical device industry experience required

Additional Skills & Expectations:

• Strict attention to detail

• Substantial understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering

• Strong problem-solving, analytical, and critical thinking skills

• Exhibits professional communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management

• Ability to manage competing priorities in a fast-paced environment

• Thrives in a collaborative team environment, including inter-departmental teams and key contact representing the organization on contracts or projects

• Advanced knowledge of statistical techniques and analytics (experience in Minitab preferred)

• Demonstrates strong leadership skills and ability to influence change

• Knowledge of applicable FDA regulations for medical device industry

• Ability to interact professionally with all organizational levels, including Sr Management, cross functional teams and external partners