Job Description

This role requires the candidate to lead the oversight and integrity of the Quality System and establishes product quality and compliance strategies. The role also acts as a liaison between the company and various governmental agencies and notified bodies to assure compliance to all quality and regulatory standards.

What You’ll Do:

• Provides vision and leadership for quality for the site by determining quality objectives and linking those objectives to company and corporate objectives

• Develops, establishes, and maintains quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established company, international (ISO), and governmental regulatory standards and agency guidelines, and to ensure customer satisfaction

• Acts as the Quality Systems Management Representative for the site

• Maintains compliance and effectiveness of the Quality Management System

• Represents the business/site to outside regulatory bodies

• Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance and drives implementation for the site

• Manages quality assurance efforts and is responsible for all regulatory compliance issues

• Develops and directs quality programs involving methods, devices, and controls

• Maintains quality system through establishing a system for internal and external inspection of raw materials and finished items purchased and production operations and processes

• Determines and establishes assigned quality organizational structure and supervisory relationships. Coaches, develops, and mentors employees in work group

• Collaborates with cross-functional colleagues to ensure achievement of standards and regulations

• Manages both sustaining and new product introduction quality teams

• Responsible for the overall direction, coordination, and evaluation of quality employees for worksite. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems

• Other duties may be assigned.

What You’ll Need:

• Bachelor’s degree, engineering or science preferred

• Five (5) or more years management experience in quality assurance and/or engineering discipline.

• Minimum of three (3) years’ experience in a medical device industry in quality management

• Position requires excellent leadership skills.

• To perform the job successfully, an individual should demonstrate the following competencies

• Designs workflows and procedures; generates creative solutions; translates concepts and information into images; uses feedback to modify designs; applies design principles and demonstrates attention to detail

• Ability to lead quality project management and present problem resolution

• Ability to listen effectively and utilize various modes to communicate with employees at all levels

• Possesses a proficient written and technical communication skillset

• Sets and achieves challenging goals and is persistent to overcome obstacles.

• Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions and follows through on commitments.

• Demonstrates accuracy and thoroughness to improve and promote quality; Applies feedback to improve performance; and monitors own work to ensure quality.