- Provide Quality oversight to ensure quality processes are in place for the qualification of lab equipment and fixtures prior to use for GxP activity.
- Responsible to ensure device testing, method development, method transfers and troubleshooting and all related documentation is compliant to applicable regulations.
- Identifies and controls Manufacturing process defects (scrap, nonconforming material, custom complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
- Actively participates in test method development, and transfer meetings to other labs representing the quality assurance function to ensure compliance with procedures.
- Support the development of Plans for development, verification/validation, technology transfer and risk management in line with applicable regulations for medical device products,
- Provide Quality oversight for the development, review, and approval of key Design History File deliverables including Verification and Validation Protocols and Reports, Risk Management deliverables, and Transfer Plans.
- Supports root cause investigations, provides compliant options for resolving lab technical and quality issues (lab investigation reports), in compliance with QMS and regulatory expectations.
- Reviews and approves complaint investigation and root cause, CAPAs.
- Analyze, trend, and report data supporting the quality system.
- Draft, reviews, and approves Quality Agreements (QAG) for equipment vendor, method developers, and service providers.
- Experience with injection molding processes, parameters, and troubleshooting is preferred.
- Mastery of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.
- Required experience with good documentation practices and cGMP standards.
- Thorough understanding of ISO 14971 from implementation through device lifecycle.
- Proficiency in the use of personal computers, especially word processing software, spreadsheets, presentation, and database software.
- Experience working in a clean room environment and performing process and equipment validations.
- Ability to perform work accurately and thoroughly and to work independently with minimal supervision.
- Must be organized and able to follow a systematic method of performing tasks and the ability to organize and direct a project to completion.
- Must be self-directed and motivated to optimally utilize the available time to organize and complete expected work within given deadlines and reasonable work schedules.
- Communication skills, both oral and written, as required to communicate effectively with others at all levels in the organization and to provide clear and concise reports and policies as needed. Ability to effectively present information publicly.
- Ability to work well with subordinates, peers and superiors in all departments.
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Quality Engineer - Flowery Branch, United States - medmix
Description
We are looking for a Senior Quality Engineerto join us at medmix, at our new Greenfield Site outside of Atlanta, Georgia USA. This exciting opportunity will allow you use your skills to identify areas of improvement and propose recommendations to management. You will lead and drive the implementation of your recommendations and assess its impact to the business. If you are eager to learn, strive for personal development, are highly motivated and organized, and a great communicator, you can help us drive medmix to the next level.
Job Description
The Senior Quality Engineer is responsible for supporting the Healthcare business by developing and executing engineering and validation strategies, plans, and protocols to include facility, equipment, process and software.
Main Accountabilities and tasks
Qualifications
Desired experience and qualifications
Work Experience: 7+ years of validation experience in a regulated manufacturing environment related to quality control of medical devices per ISO 13485 and 21 CFR 820.
Education: BS degree in engineering field
Other:
