Associate Director of Quality

Summary:

Provides QA/QC leadership across all departments, giving input to senior management, for product and process improvements. Develops a strong culture of quality in the organization.

Essential Responsibilities: The employee may be required to perform all or a combination of the following essential responsibilities as determined by business necessity.

Further develop and drive changes to a Quality Management System (QMS) that is compliant, effective, and quickly responds to the needs of a diverse and evolving product line
Lead the upgrade of an organization and QMS to ISO certification and accommodate FDA level design and manufacturing
Manage a group QA/QC professionals and mentor, motivate, and organize the teams
Responsible for maintaining and improving a quality system for both US and European operations
Manages quality assurance, quality control, supplier quality, incoming inspection, calibration, complaint handling, software validation, and document control
Plan, coordinate and direct quality strategies for new and existing products, including raw materials, materials in process, and finished goods

Direct investigations and implement corrective actions to resolve any complaints or non-compliance
Be comfortable working with employees from all departments and interfacing with customers regarding quality plans and audits

Non-Essential Responsibilities: In addition to the essential responsibilities listed above, the employee may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.

Qualifications:

Preferred: ISO13485 implementation experience
Bachelor’s degree in Science or Engineering
10+ years quality systems/regulatory compliance experience, preferably with in-vitro diagnostics or Life Sciences
Experience with laboratory instrumentation, consumables, and/or reagents is a plus
5+ years managing a quality organization with a diverse product portfolio
Expertise with ISO 9001 and GMP standards and practices
Experience with and ability to develop process within an electronic quality management system (eQMS)
Ability to implement, prioritize, and direct multiple projects simultaneously
Demonstrates leadership ability and has excellent people management skills
Strong written and verbal communication skills