Page 1 of 3
JOB DESCRIPTION
Job Title: Sr. Ops QA Mgr/Dir.
Date: May 20, 2015
Minimum Education:
Preferred Education:
Minimum Years Experience:

BS degree in Engineering or related field.

Knowledge of GMP, ISO 13485, MDD, CMDR, CMDCAS

Training in r Process Improvement.

Certificate of Professional Engineer (PE) or MS Degree.

Lean Sigma training or certification.

Certified Quality Engineer (CQE)

Certified Quality Auditor (CQA)
 Five (5) years experience in a highly regulated field.
Preferred Years Experience: 
Five (5) years expertise in Class (II) or Class (III) Medical Device
Industry.
Position Description (brief summary of job purpose):
Ensure products and assemblies manufactured in Southern, CA, meet specifications and are developed and manufactured with highest product quality and meet all applicable product quality, design and manufacturing process requirements. Provide leadership in areas of process engineering, product quality assurance and quality engineering to drive continuous process and product improvements. The available position is a contractor role that will last 9-12 months, travel expenses will be reimbursed, and starts immediately.
Position Responsibilities/Authority (in bullet form, describe the key accountabilities or deliverables of the position):
 Conduct all engineering activities in compliance with FDA Regulations, ISO 13485,
MDD, CMDR, CMDCAS and other national and international quality and regulatory requirements and standards.
 Lead the product quality assurance and quality engineering aspects of activities to drive strong engineering and technical knowledge and application.
 Establish quality assurance, engineering programs, and initiatives to ensure products and assemblies are developed and manufactured in accord with applicable requirements.

Page 2 of 3
JOB DESCRIPTION
Job Title: Sr. Ops QA Mgr/Dir.
Date: May 20, 2015
 Conduct investigations, root cause analysis and provide corrective and preventive actions based on sound engineering analysis and review. Provide effective solutions that will drive continuous and measurable improvements.
 Work closely with Manufacturing/Operations, R&D and other departments to ensure highest quality products and processes are developed and deployed and are engineering sound. This includes product design testing, process testing, characterization, qualification, validation, risk analysis/FMEA, etc.
 Demonstrate and educate use of quality engineering tools (Lean Sigma) within the organization to drive methodical approach to design and process development, implementation and improvement. Apply same approach to existing processes including utilization of new technologies. The tools include, but are not limited to, six sigma, analytical statistics, advanced statistical engineering, design of experiments, and other proven tools.
 Demonstrate superior engineering/critical thinking based on both driving business objectives and product quality improvements.
 Demonstrate solid understanding of internal and applicable external policies, procedures and standards.
 Develop systems for the identification, analysis, correction, and prevention of quality issues.
 Work with local regulatory compliance manager to ensure effective compliance to the product development protocol and other applicable systems.
 Manage quality engineers and/or technicians as assigned and provide technical leadership.
 Participate in projects as assigned including operations and/or R&D projects.

Communicate issues and opportunities to manager.

Page 3 of 3
JOB DESCRIPTION
Job Title: Sr. Ops QA Mgr/Dir.
Date: May 20, 2015
Basic Qualifications (basic skills and experiences necessary to perform the job: must be relevant, objective, and non-comparative):
 Good written and verbal communication skills
 Quality Engineering Statistical Tools.
 Presentation.
 Excellent PC skills.

Strong problem solving skills.

Good people management skills.

Effective interpersonal skills.
Desired/Preferred Qualifications (skills and experiences beyond Basic
Qualifications that help identify the best possible applicant):

Supervisory skills.

Effective project management skills.
Physical Job Requirements (physical requirements necessary to perform the job):

Specific vision abilities include close vision, distance vision, and color vision.

Work in a clean room and laboratory.

Exposure to some chemicals.

Constant walking.
 Ability to lift 25 to 50 lbs.