Supports maintenance of the quality system in accordance with 21 CFR 820, 803, 806 and ISO 13485.
Supports preparation and maintenance of compliance to ISO 14971 Risk Management
Implement quality methods throughout the organization; drive the use of quality tools in operations and product development, assist in resolving major quality issues
Support activities concerned with development, application, and maintenance of quality standards for manufacturing processes, materials, and products.
Position Specific Duties and Responsibilities
Ensure that the quality system is compliant with 21 CFR 820, 803, 806 and ISO 13485.
Promote awareness of the quality system and provide training to individuals across the organization on quality management philosophies, tools, techniques and best practices.
Provide training and direction, as required, to junior team members within the Quality department. Implement cost of quality concepts, including quality cost categories, data collection, reporting etc. for manufacturing.
Conduct inspections of components and subassemblies as required and document compliance to approved specifications and procedures.
Initiate and coordinate laboratory testing of raw materials, assemblies, finished goods and environmental conditions.
Devise sampling procedures and designs and develop forms and instructions for recording, evaluating, and reporting quality and reliability data.
Schedule and conduct quality system audits of material and service suppliers.
Coordinate and oversee sterilization validation activities.
Ensure systematic planning, and controlling of product and process quality in manufacturing
Processes for planning product and service development
Implement a validation program for new/changed materials, equipment, processes and components.
Support a systematic program for quality problem solving and continuous improvement in manufacturing
Implement and support quality improvement models
Corrective and preventive action
Overcoming barriers to quality improvement
Quality system support
Complaint handling and investigation
CAPA handling and investigation
Returned heart program
Guidance for completion of failure investigations
Participation in external audits – develop responses to queries during and following the audit
Responsibility and Authority Affecting Quality
Initiate action to prevent the occurrence of nonconformities relating to the product, process and quality system.
Identify and record potential problems relating to the product, process and quality system.
Initiate, recommend or provide solutions through designated channels.
Record and/or report all instances of customer feedback on product.
Verify the implementation of solutions.
Reports verbally and in writing to the Quality Manager regarding the progress and results of projects.
Skills and abilities (required for the job)
Excellent communication skills
Excellent writing skills
Strong organizational skills
Ability to handle multiple tasks simultaneously
Comfortable working independently and as a part of a cross-functional team
Exhibits self-reliance in managing personal workload and schedule of deliverables
Education, experience and training (required for the job)
ASQ Certified Quality Engineer and Six Sigma black belt preferred.
Bachelor’s Degree in Engineering or Life Sciences required, Master’s Degree preferred.
7-10 years of experience in a quality related role.
At least 5 years working at a class II or III medical device company.
Note: An advanced degree in Engineering or Life Sciences accepted in lieu of professional experience.
Thorough understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics.
Thorough understanding of a quality system and its development, documentation and implementation with respect to domestic and international standards and requirements.
Thorough understanding of the audit process, including types of audits, planning, preparation, execution, reporting results and follow-up.
Ability to develop and implement quality programs, including tracking, analyzing, reporting and problem solving.
Ability to plan, control and assure product and process quality in accordance with quality principles which include planning processes, material control, acceptance sampling, and measurement systems.
Thorough knowledge of statistical analysis, reliability, maintainability and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting.
Thorough understanding of problem solving and quality improvement tools and techniques, including management and planning tools, preventive and corrective actions, and how to overcome barriers to quality improvements.
Ability to acquire and analyze manufacturing data using appropriate standard quantitative and statistical methods across a spectrum of business environments to facilitate process analysis and improvement.
Work Station Area: Office, Laboratory and Controlled Environment Manufacturing Area
Special Factors in the Work Area:
The working environment is indoors and is seasonally heated and cooled with minimal noise levels.
The position requires considerable sitting, typing and the ability to move objects of less than 25 pounds.
The position requires the ability to communicate in person, telephonically and via email.
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