Description
Purpose of Position:Evaluates, revises, and applies technical quality assurance protocols/methods to inspect and test in-process raw materials, production equipment, and finished products for medical devices. Develop design/pre-production and production test configuration, product testing and feedback, quality assessments, validations and incorporation of quality goals throughout the design and early production phases of the project. Under supervision performs analysis and identifies trends in the inspection of finished products, in-process materials and bulk raw materials, and recommends corrective actions when necessary. Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed. May assure compliance to in-house and /or external specifications and standards, such as GMP's, FDA, Health Canada and ISO regulations. Assists in the efforts of organizing, documenting, and interpreting inspection support documents and records.
MAJOR DUTIES AND RESPONSIBILITIES:
- Works on problems in which analysis of situations or data require an evaluation of various established factors. Maintains and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
- Exercises judgment within defined practices and support quality systems development ensuring FDA Quality Systems Regulation, ISO 13485:2003 and MDD requirements, including design and manufacturing quality reporting, problem solving, and technical support for all phases of the product life cycle.
- Prepares documentation for inspection/testing procedures to current specifications and standards. Applies, revises and maintains quality standards for processing materials into partially finished or finished products.
- Assist product development and manufacturing teams implementing simple statistical techniques, meeting FDA Quality System Regulation and ISO requirements.Performs monitoring, trend analysis, and completion of product improvement projects based on manufacturing experience, supplier, or process related studies when assigned.
- Assist in meeting sterilization validation requirements to support teams in protocol development, execution, and revalidation activities.
- Conduct product testing and release activities, generating and implementing appropriate test protocols. Accurately generate standard written reports.
- Complete assigned projects (including product enhancements) in an aggressive manner consistent with corporate objectives. Actively participate in determining day-to-day tasks.
- Maintain Quality Performance indices in support of Customer Focused Quality programs.
- Coordinate the reporting, analysis, and corrective actions for material non-conformances utilizing established quality engineering techniques and Material Review Board actions.
- Improve and revise existing specifications, test methods, sampling plans, and related written procedures.
- Serve as a Quality Engineering representative on various project teams.
- Maintain accurate documentation of concepts, designs, drawings, and processes.
- Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to Conceptus products. Maintain and oversee outside suppliers and consultants as required.
- Maintain GMP systems, including FDA Quality System Regulation, pre-clinical testing programs, and post production GMP compliance. Provide support in the resolution of product complaints and/or safety issues.
- Maintain a professional, credible image with key physicians, consultants, vendors, and co-workers. Complete all required training tasks in a timely manner. Perform other duties as assigned.
EDUCATION REQUIREMENTS:
- Requires a Bachelors/Masters degree. Prefer mechanical engineering or process engineering but will consider chemistry, biochemistry, microbiology or related discipline or equivalent experience.
- CQE or equivalent preferred.
- Experience with Class III, PMA devices
EXPERIENCE REQUIREMENTS:
- 5 Years in QE or comparable position in the Medical Device industry.
- 510k experience preferred
- Statistical Techniques, Failure Analysis and Process Validation experience
- Familiar with Word, Excel, MiniTab, Document Control database
- Familiar with FDA, ISO, Canadian Health and other regulatory requirements
- Effective written and verbal communication skills.
To find out more about Real please visit www.realstaffing.com