Director, Quality Assurance and Regulatory Compliance

Director, Quality Assurance and Regulatory Compliance

 

We are a small, private, and well funded (venture backed) medical device company launching our first product.  This position will play an important role with significant responsibility for successfully developing with cross-functional input, policies and procedures to establish the company?s Quality System (QS).

 

This individual should have previous medical device experience.

 

This position will report directly to the Vice President of Operations and will serve as a key driver for our QS to be compliant with US FDA regulations, as well as serve the business needs of the company.

 

Job Responsibilities:

Create, with cross-functional input, policies and procedures to establish the company Quality System (QS). 

 

Update and maintain QS policies and procedures as needed to reflect changes in current interpretation of requirements and/or changes in the company size, structure or operations.

 

Create and be responsible for training program to communicate QS to organization at all levels.

 

Create and be responsible for document management systems for: 1) change control of internal quality procedures and records, 2) maintenance of certain quality records (DHFs, DHRs, and others), 3) library of external standards which may apply to company and/or company products, 4) library of trade publications and medical journals, as service to company.

 

Create and be responsible for internal and external audit program.  Create and implement audit schedule to ensure key suppliers and all elements of QS are assessed on a regular basis.

 

Create and be responsible for compliant handling program, including compliant receipt, investigation, follow up, record keeping and trend analysis.

 

Create and be responsible for corrective and preventive action (CAPA) program.

 

Create program for MDR reporting.  Be responsible for filing such reports.

 

Create and be responsible for field service and all return goods processing required.

 

Responsible for federal and state establishment registration and device listing compliance.

 

Participate in audits by outside agencies, including FDA and California assessments.

 

Lead regularly scheduled management review of QS.

 

Establish and maintain files for device electrical safety, including (but not limited) to ISO and UL standards.

 

Directly supervises employees in the Quality and Document control departments. 

 

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.

 EDUCATION and/or EXPERIENCE

Bachelor's degree (B.A.) from four-year college or university; seven years related experience and/or training; or equivalent combination of education and experience.

 

Minimum of seven years experience in Quality System (QS) or equivalent combination of education and experience in an FDA regulated industry

 

Excellent computer skills with specific skills in Microsoft Office and Omnify.

 

Knowledge of FDA regulations and ISO standards as they apply to Document Control.

 

Demonstrates excellent organizational and communication skills, both written and verbal.

 

Experience with automated document control systems.

 

Strong written and oral communication skills.

 

Ability to establish and maintain good working relationships with all departments including the management team.

 

We are seeking enthusiastic individuals to join our extraordinary team. We recruit the highest level of talent and provide a positive working environment that fosters growth and creativity.  Aperon is dedicated to the following values: integrity, passion, teamwork and customer-focus.

Want to work with a passionate team of innovative scientists, engineers and business people? Send us your resume to shebrok@aperon.com .