JOB DESCRIPTION:

Job Summary:

The Director of Quality Engineering is responsible for establishing the technical quality policies and objectives related to Research/Development and Operations. This individual reports directly to the VP of Quality and interacts with a broad range of engineering and management team members to set and implement compliant engineering policies and strategies. The Director of Quality Engineering works cross-functionally with Operations, Regulatory, R+D, Sales, Training and Marketing to assure compliance with applicable QSR, cGMP and ISO13485:2003 regulations. As part of design control, interacts regularly with Research and Development to establish new product criteria and associated implementation strategies.  

Oversees all aspects of an organization's quality engineering functions ensuring products meet corporate standards as well as all applicable government regulations. Develops procedures for testing of final product and makes decisions regarding the issuance of recall notices.

Requires a bachelor's degree with at least 10 years of related experience. Familiar with a variety of engineering concepts, practices, and procedures. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. Leads and directs the work of others. A wide degree of creativity and latitude is expected. Typically reports to VP of Quality.

Duties & Responsibilities:

• Responsible for the compliance of the technical aspects of the company by successfully integrating these activities with other functional areas within the company, including: Quality, Regulatory, and Clinical; R&D/Product Development; Finance; and Commercial Group.
• Creates long-range quality plans for the organization focusing on:  Design Control, Risk Management, Statistical Sampling Methods, Supplier Quality, NCMRs, Management Reviews, Manufacturing Quality Control.   
• Determines actual organizational structure and allocation of responsibilities within the Operations group. 
• Creates, develops and communicates a strategic vision for the quality department through facilitation of ongoing management staff meetings and department communications meetings.  Influences individual, group and organizational goals, rewards and systems.
• Makes recommendations regarding problems that cross multiple organizational areas.  Provides creative solutions to key problems facing the organization.
• Provides direction and coaching to employees throughout Acclarent, particularly exempt level and management employees within the quality areas.    
  

JOB REQUIREMENTS:

Qualifications:

• Bachelors or Masters degree (preferred) in a related technical and/or business discipline.
• Minimum of ten (10) years? of demonstrated leadership in the medical device industry or a directly related field.  Director or VP level experience leading organizations from early startup phase through successful commercialization in US and International markets. 
• The ability to apply principles of logical and scientific thinking to define problems, collect data, establish facts and draw valid conclusions.
• The ability to interpret an extensive variety of abstract and concrete concepts and synthesize them into technical, financial, regulatory, and business solutions.
• Strong mathematical skills (i.e., frequency distributions, reliability and validity of tests, normal curve, analysis of variance, correlation techniques, sampling theory or factor analysis).
• Knowledge of and compliance with applicable Quality System requirements (e.g., QSRs, ISO and MDD requirements).
• Strong written and verbal communication skills to communicate effectively at all levels. 
• Good presentation skills to deliver speeches and/or presentations effectively to a variety of audiences.
• Strong people management skills.

To apply for this position, please copy and paste the following link into your browser address bar: http://acclarent.contacthr.com/17951934