Director, Quality Assurance and Regulatory Compliance Vista CA

Director, Quality Assurance and Regulatory Compliance

 

 

Job ID: Job-2355

Job Title:      Director, Quality Assurance and Regulatory Compliance

location:       Vista, CA

Jobtype:        Permanent

Rate:   150K - $200K +bonus

Primary Skills:

Description:    Requirements

Bachelors in a scientific discipline required with 7-10 years experience in the medical device or pharmaceutical industry; strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education.

Demonstrated knowledge of FDA regulations, ISO 13485:2003, CMDR, Medical Device Directive Regulation (93/42EEC) and other national and international regulations and standards.

Experience with direct contact with FDA and ISO Notified Bodies.

Knowledge of process design and implementation, change control, auditing, and document management systems.

General knowledge of statistical analysis.

Demonstrated organizational, management and communication skills.

 

Responsibilities

Directly supervises employees in the QA/QC Department. 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.

Oversees investigation of customer complaints regarding quality, safety and effectiveness of products and participates in corrective action determinations.

Directs the activities of the Quality Department (Quality Assurance, Quality Control) to ensure compliance with all appropriate regulations and standards, including FDA, ISO 13485:2003, CMDR, MDD, and AATB.

Ensures the quality system is established, implemented and maintained in compliance with all applicable FDA Quality System Regulations, ISO 13485:2003, the Medical Device Directive (93/42EEC), and the Canadian Medical Device Regulations (CMDR).

Oversee internal audits, vendor audits and vendor qualification, corrective and preventive action system, non-conforming materials, Material Review Board, calibration program, and document control.

Oversee product quality reviews, management reviews and preparation of quality reports.

Ensure that all projects and validations are in compliance with QSR, and ISO requirements.

Ensure dependable and timely results from quality control, including process control and support for process changes in compliance with QSR, and ISO requirements.

Participate in review of product labeling.

Participate in FDA inspections, ISO certification and customer audits.

Participate in evaluation of new product opportunities.

Identify and implement opportunities for continuous improvement.

Interact and coordinate activities with other departments, external vendors and customers.

Evaluate the performance of the Quality Department employees with the intent of increasing their competency.

 

Email resume in Word to JeffAltman@TheBigGameHunter.us. Please include the job code for the position with your resume. NOTE: WE WILL ONLY RESPOND IF YOUR RESUME APPEARS TO FIT A ROLE

 

PAID RELOCATION. NO OVERSEAS RESUMES. NO 3RD PARTIES. Applicants for employment in the US must possess work authorization which does not require sponsorship from the employer for a visa.

 

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