Director of Quality Assurance
Zeltiq - Pleasanton, CA

This job posting is no longer available on Zeltiq. Find similar jobs: Director Quality Assurance jobs - Zeltiq jobs

Description: With minimal direction, plans and executes activities related to quality assurance of all products. Is responsible for building the Quality Department infrastructure to assure products conform to company, industry, regulatory and international standards.

Oversees the quality system to ensure it complies with the U.S. FDA 21 CFR 803, 806, and 820, the current Canadian Medical Devices Regulations (SOR 98-282), Medical Device EN ISO 13485: 2003, Directive (MDD) 93/42/ECC and MHLW Ordinance No. 169.

Reports To: Senior Director of Regulatory Affairs and Quality Assurance

Principle Responsibilities and Duties:
Note: The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.

Responsible for recruiting, managing and leading a high-performing, knowledgeable Quality departmental staff

Establish and continually improve quality systems

Promote and develop reliability improvement

Ensure quality products and processes including contract manufactured products

Continually improve QSR, ISO, CMDR and other standard compliance

May be designated as Management Representative for the company. May serve as point of contact for FDA and international regulatory bodies in the area of Quality and Regulatory Compliance.

May be designated as Responsible Engineering Manager as defined in MHLW Ordinance no. 169.

Report to top management on the performance of the quality management system and any need for improvement.

Promote awareness of regulatory compliance and customer requirements throughout the organization.

Work closely with other departments to ensure projects conform to quality requirements.

Organize, plan, lead, and/or manage and conduct routine internal and supplier audits to assure compliance with company, state, federal, and international standards.

Organizes, plans, leads and/or manages quality-related projects in alignment with company goals.

Aids in setting the policies, budget, goals, and strategy for the Quality Assurance department.

Implements training programs for cGMP/QSR and ISO compliance.

Monitors/improves manufacturing processes and provides regular reports of process and product improvements.

Stays up-to-date and follows all procedures related to this job that can affect the quality of products or services provided to our customers.

Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies

Experience, Education, Training, Traits:
BS or BA degree plus ten years experience implementing quality assurance systems, and at least five years in medical devices preferred.

Minimum of three years of experience in recruiting, managing and leading high-performing and knowledgeable staff strongly preferred.

Knowledge of FDA, CA-FDB, and ISO regulations/standards, including requirements for biocompatibility.

Working knowledge of project planning and management including use of PM software such as MS Project is preferred

Ability to focus on and achieve scheduled milestones, including contingency planning.

Knowledge of FDA and international Quality Systems and Design Control requirements and their application to projects from design inception to manufacturing release.

Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.

Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.

Certifications in the Quality (or related) fields (i.e. CQE, CQA, RAC, etc.) are a plus.

Language and Verbal Skills

Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or government regulations.

Ability to write reports, specifications, business correspondence, and procedure manuals.

Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Ability to clearly and concisely convey project accomplishments, obstacles, issues and status to project team members.

Math Skills

Ability to work with mathematical concepts such as probability and statistical inference.

Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Ability to use MS Excel to perform calculations and interpret project results/data.

Ability to design statistical experiments and interpret results related to quality issues, such as process validation and gage repeatability.

Analytical and Reading Skills

Ability to define problems, collect data, establish facts, and draw valid conclusions.

Ability to read technical and clinical literature and documents and extract important concepts.

Physical Requirements

While performing the duties of this job, the employee is regularly required to sit. The employee will be required to use a computer for up to 8 hours consecutively. The employee frequently is required to use hands to finger, handle, or feel objects, tools, or control and talk or hear. The employee is occasionally required to reach with hands and arms and be mobile.

Specific vision abilities required by this job include close vision and color vision.

Ability to travel 10-20% of the time, domestically and/or internationally.

Work Environment

The noise level in the work environment is usually moderate. Some work will be required to be performed in animal and clinical laboratories, where the employee must employ standard techniques to protect against chemical and biological hazards. Some light machining and prototyping activities will involve moderate noise levels (i.e. power drill) and moderate dust or debris exposure.

Description: With minimal direction, plans and executes activities related to quality assurance of all products. Is responsible for building the Quality Department infrastructure to assure products conform to company, industry, regulatory and international standards.

Oversees the quality system to ensure it complies with the U.S. FDA 21 CFR 803, 806, and 820, the current Canadian Medical Devices Regulations (SOR 98-282), Medical Device EN ISO 13485: 2003, Directive (MDD) 93/42/ECC and MHLW Ordinance No. 169.

Reports To: Senior Director of Regulatory Affairs and Quality Assurance

Principle Responsibilities and Duties:
Note: The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.

Responsible for recruiting, managing and leading a high-performing, knowledgeable Quality departmental staff

Establish and continually improve quality systems

Promote and develop reliability improvement

Ensure quality products and processes including contract manufactured products

Continually improve QSR, ISO, CMDR and other standard compliance

May be designated as Management Representative for the company. May serve as point of contact for FDA and international regulatory bodies in the area of Quality and Regulatory Compliance.

May be designated as Responsible Engineering Manager as defined in MHLW Ordinance no. 169.

Report to top management on the performance of the quality management system and any need for improvement.

Promote awareness of regulatory compliance and customer requirements throughout the organization.

Work closely with other departments to ensure projects conform to quality requirements.

Organize, plan, lead, and/or manage and conduct routine internal and supplier audits to assure compliance with company, state, federal, and international standards.

Organizes, plans, leads and/or manages quality-related projects in alignment with company goals.

Aids in setting the policies, budget, goals, and strategy for the Quality Assurance department.

Implements training programs for cGMP/QSR and ISO compliance.

Monitors/improves manufacturing processes and provides regular reports of process and product improvements.

Stays up-to-date and follows all procedures related to this job that can affect the quality of products or services provided to our customers.

Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies

Experience, Education, Training, Traits:
BS or BA degree plus ten years experience implementing quality assurance systems, and at least five years in medical devices preferred.

Minimum of three years of experience in recruiting, managing and leading high-performing and knowledgeable staff strongly preferred.

Knowledge of FDA, CA-FDB, and ISO regulations/standards, including requirements for biocompatibility.

Working knowledge of project planning and management including use of PM software such as MS Project is preferred

Ability to focus on and achieve scheduled milestones, including contingency planning.

Knowledge of FDA and international Quality Systems and Design Control requirements and their application to projects from design inception to manufacturing release.

Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.

Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.

Certifications in the Quality (or related) fields (i.e. CQE, CQA, RAC, etc.) are a plus.

Language and Verbal Skills

Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or government regulations.

Ability to write reports, specifications, business correspondence, and procedure manuals.

Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Ability to clearly and concisely convey project accomplishments, obstacles, issues and status to project team members.

Math Skills

Ability to work with mathematical concepts such as probability and statistical inference.

Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Ability to use MS Excel to perform calculations and interpret project results/data.

Ability to design statistical experiments and interpret results related to quality issues, such as process validation and gage repeatability.

Analytical and Reading Skills

Ability to define problems, collect data, establish facts, and draw valid conclusions.

Ability to read technical and clinical literature and documents and extract important concepts.

Physical Requirements

While performing the duties of this job, the employee is regularly required to sit. The employee will be required to use a computer for up to 8 hours consecutively. The employee frequently is required to use hands to finger, handle, or feel objects, tools, or control and talk or hear. The employee is occasionally required to reach with hands and arms and be mobile.

Specific vision abilities required by this job include close vision and color vision.

Ability to travel 10-20% of the time, domestically and/or internationally.

Work Environment

The noise level in the work environment is usually moderate. Some work will be required to be performed in animal and clinical laboratories, where the employee must employ standard techniques to protect against chemical and biological hazards. Some light machining and prototyping activities will involve moderate noise levels (i.e. power drill) and moderate dust or debris exposure.

Zeltiq - 20 months ago - save job - block
Recommended Jobs
Program Quality Engineer
L-3 Communications - Menlo Park, CA
L-3 Communications - 11 days ago

Manager – Controller Quality and Reliability...
Micron Technology, Inc - Milpitas, CA
Micron Technology, Inc - 16 days ago

Director, Quality Assurance/Engineering
Scanadu - Moffett Field, CA
Scanadu - 5 days ago