Job Responsibilities

• Drive the development of *** ’s Quality Assurance strategy and policies.

• Lead Quality Assurance operations including investigations, risk assessments/management, audits, and company-wide training. 

• Provide Quality Assurance and compliance oversight for suppliers and contract manufacturers.

• Direct and implement advancement of *** ’s Quality Management System and document hierarchy (e.g. quality manual, SOPs).

• Provide Quality input at Product Development Team Meetings. 

• Author/revise, review and approve controlled documents. 

• Supervise Quality Assurance direct report(s) who may include internal staff and/or consultants.

• Ensure optimal workforce planning, retention, coaching, and performance management of staff. 

• Mentor and manage the growth and development of direct reports.

• Present Quality Assurance plans and status to partners and senior audiences, both internally and externally.

• Record test data, applying statistical quality control procedures as required.

• May prepare graphs or charts of data or enter data into computer for analysis. 

• May calibrate measuring and monitoring equipment according to established policies and procedures.

• Monitor actions determined via Management Review and that those allocated to employees for action, and carried out in a timely manner.

• Oversee and monitor for reporting to Top Management that agreed Improvement Objectives are identified and implemented and implemented as intended.

• Assures necessary data is collected, analyzed, and reported to Top Management pertaining to the status of Management Review topics. 

Job Requirements

• Ability to effectively lead the QA function and engage senior management on quality issues 

• Strong project management skills with an emphasis on critical thinking and problem solving 

• Outstanding written and verbal communication skills including presentation effectiveness

• Ability to coordinate & influence across various parts of the company and with multiple external stakeholders 

• Committed to the values of integrity, accountability, transparency, scientific rigor and drive

• Experienced in implementing ISO 9001 Quality Systems

• Certified ISO 9001 Lead Assessor

• A plus if also a Certified Quality Engineer (CQE)

• Years of Experience: 5+