The Quality Engineer, Operations develops, practices, and promotes quality principles throughout the organization to achieve defined customer quality requirements and required regulatory compliance. In addition, this individual provides leadership and guidance to the organization to maintain compliance with QSR and ISO certification.
This role is responsible for independently identifying, proposing solutions and implementing improvements to the quality and effectiveness of products and processes.
The position will oversee that the quality system requirements are effectively established and effectively maintained in accordance with 21 CFR Part 820 and ISO13485 (and other regulations as applicable) and for providing data regarding the performance of the quality system that will be presented to management with executive responsibility for review.
This role utilizes extensive internal and external partnering skills and must be knowledgeable with other cross-functional disciplines and processes such as R&D, Regulatory, Clinical and Manufacturing.
All positions are responsible for following applicable AMS policies and procedures as defined by their manager.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Product Development Engineering Support:
Continuation Engineering support
- Perform functional quality tests on incoming, in-process and finished goods material accurately, and in a timely and efficient manner.
- Record and report results of inspections, failure analysis, material discrepancies, and defect data.
- Perform detailed visual inspection of material to determine product quality.
- Movement and disposition of material and movement of acceptable product into use in a timely manner.
- Make recommendation on disposition of questionable product.
- Review lot history information related to product manufactured at AMS.
- Data collection, analysis, and creation of presentation material for metric reporting and trending.
- Help drive the Non-conformance/Corrective Action process.
- Perform root cause failure analysis and disposition of returned material.
- Creation of work instructions for inspection and product improvements.
- Act as a liaison between Quality and other functional departments.
- Maintains company-wide calibration database.
- Primary contact with Calibration service providers.
- Supports Field Service Engineers.
- Participate on validation projects when needed.
- Additional duties and responsibilities may be assigned as required.
Team Support *
- Provide manufacturing support, product line and MRB support.
- Independently identifies and implements improvements to the quality and effectiveness of products and processes.
- Support internal/external audits as needed.
- Supports investigation, prioritization and coordination of proposed documentation changes.
- Provides technical assistance for manufacturing quality problems.
- Selects and applies appropriate statistics techniques for testing of materials and incoming components.
- A Bachelor’s degree in science or engineering (electrical preferred) is required. Master’s degree is a plus.
- Previous laser manufacturing experience is a plus.
- Lead Auditor Certification is a plus.
- Must be knowledgeable in Quality System Regulations, Medical Device Directive and ISO13485 Quality Standards.
- Minimum of five years medical device quality systems experience required.
- ASQ or other quality related certifications (CQE, CQA, CRE, ISA Lead Assessor)
- Ability to read and interpret drawings and design specifications
- Proficient in technical writing skills and communications
- Proficient computer skills using Microsoft Office Suite, specifically Outlook, Word, and Excel.
- Good organizational, listening, and verbal / written communication skills with demonstrated ability to follow instructions and processes.
- Able to be proactive and self-motivated.
- Able to interact and communicate with all levels of AMS staff.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
American Medical Systems - 18 months ago
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