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SR DIRECTOR, QUALITY-2511131120
Description
Acclarent, Inc., a member of the J&J Family of Companies is actively recruiting for a Senior Director, Quality to be located in Menlo Park, CA.
Acclarent, Inc. is a medical device company in Menlo Park, CA that was established in June of 2004. The company is dedicated to the development of innovative devices providing new technologies to further meet the needs of ENT patients.
Acclarent's initial focus is on achieving the goals of sinus surgery with novel, endoscopic, catheter-based tools - Balloon Sinuplasty™ devices. Through the Balloon Sinuplasty™ technology and our Relieva® product portfolio we offer ENT patients another option to conventional endoscopic surgical technologies. FDA clearances for these devices were completed in 2005 and the products were commercially launched in the US that same year.
The Sr. Director of Quality is directly responsible for establishing quality policies, strategies and objectives for the company in collaboration with the Senior Management Team. The Sr. Director of Quality works cross-functionally with Operations, Regulatory, R+D, Sales, Training and Marketing to assure all operations of the company comply with applicable QSR, ISO and FDA regulations. The Sr. Director of Quality also serves as the Management Representative
Creates long-range quality plans for the organization focusing on: Standard Operating Procedures and policies, Document Control, Training, CAPA system, Failure Analysis and Complaint Handling, Supplier Quality, NCMRs, External and Internal Auditing, Management Reviews, Manufacturing Quality Control, etc. Determines organizational structure and allocation of responsibilities within the Quality group and works closely with the Senior Management Team to determine resource allocation. 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 issues that cross multiple organizational areas. Provides direction and coaching to employees throughout Acclarent, particularly exempt level and management employees within the quality area.
Qualifications
Bachelor’s or Master’s 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. 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. Strong problem solving skills, time management and communication skills are required. Strong people management skills.
This position is located in Menlo Park and requires 25% travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-California-Menlo Park
Organization: Acclarent, Inc. (6206)
Job Function: Quality (Generalist)
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
SR DIRECTOR, QUALITY-2511131120
Description
Acclarent, Inc., a member of the J&J Family of Companies is actively recruiting for a Senior Director, Quality to be located in Menlo Park, CA.
Acclarent, Inc. is a medical device company in Menlo Park, CA that was established in June of 2004. The company is dedicated to the development of innovative devices providing new technologies to further meet the needs of ENT patients.
Acclarent's initial focus is on achieving the goals of sinus surgery with novel, endoscopic, catheter-based tools - Balloon Sinuplasty™ devices. Through the Balloon Sinuplasty™ technology and our Relieva® product portfolio we offer ENT patients another option to conventional endoscopic surgical technologies. FDA clearances for these devices were completed in 2005 and the products were commercially launched in the US that same year.
The Sr. Director of Quality is directly responsible for establishing quality policies, strategies and objectives for the company in collaboration with the Senior Management Team. The Sr. Director of Quality works cross-functionally with Operations, Regulatory, R+D, Sales, Training and Marketing to assure all operations of the company comply with applicable QSR, ISO and FDA regulations. The Sr. Director of Quality also serves as the Management Representative
Creates long-range quality plans for the organization focusing on: Standard Operating Procedures and policies, Document Control, Training, CAPA system, Failure Analysis and Complaint Handling, Supplier Quality, NCMRs, External and Internal Auditing, Management Reviews, Manufacturing Quality Control, etc. Determines organizational structure and allocation of responsibilities within the Quality group and works closely with the Senior Management Team to determine resource allocation. 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 issues that cross multiple organizational areas. Provides direction and coaching to employees throughout Acclarent, particularly exempt level and management employees within the quality area.
Qualifications
Bachelor’s or Master’s 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. 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. Strong problem solving skills, time management and communication skills are required. Strong people management skills.
This position is located in Menlo Park and requires 25% travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-California-Menlo Park
Organization: Acclarent, Inc. (6206)
Job Function: Quality (Generalist)
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
