- Supplier management process owner including creating and managing supplier audit schedule. Contributing supplier-related data/information to ongoing monthly Quality reviews and quarterly Quality Management Review meetings.
- Support medical device reporting assessments and investigations requiring working experience with quality and regulatory standards, including but not limited to FDA 21 CFR Part 820, 21 CFR Part 803, ISO 13485:2016, and ISO Risk Management for Medical Devices).
- Experience with the Post-Market Surveillance Analyst to monitor, analyze, and trend complaints. Assist with the complaint process including coordinating with and gathering sufficient data from customers, field representatives, internal staff, and outside experts.
- Experience with NCRs, MRB, Complaint and Corrective and Preventive action activities to support other Quality Engineers in the team as required.
- Participate in performing internal and external audits to ensure compliance
- BSME or equivalent experience in a medical device environment
- Five or more years of relevant medical device industry experience
- Sound understanding of quality assurance concepts.
- Full understanding of ISO 13485 and FDA 21 CFR Part 820
- Full understanding of ISO 17025 for testing and calibration laboratories
- Full understanding of ISO 14971 safety risk management practices
- Ability to lead quality and supplier interaction meetings.
- Full understanding of part qualification processes
- ASQ Certification a plus (e.g. CQA, CQIA, CQT, CQPA, CQE, etc.)
- Effective communication, and ability to work both independently and in a team environment and to present detailed technical data both internally and externally.
- Effective oral/written communication skills with preferences in technical writing, presentations, reports, data analysis, etc.
- Experience with sterile disposable devices a plus.
- Proficient in analyzing product data to perform statistical and trend reporting.
- Proficiency with quality tools/methodologies, including design control, risk analysis (hazard analysis), design FMEA, process FMEA, statistical analysis, DOE, and MSA (Gauge R&R)
- Working Experience within ISO 13485:2016, ISP 14971, GMP guidelines, FDA CFR820, European MDD/MDR, and MDSAP.
- Knowledge of global regulations for medical device reporting and terminology is a plus.
- Able to handle multiple tasks in a fast-paced, results-oriented environment.
- Excellent data entry and analysis skills.
- Self-motivated and result-driven attitude and strong problem-solving skills.
- Working knowledge of Microsoft Word, Excel, PowerPoint, and Project.
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Sr. Quality Compliance Engineer - Redmond, WA, United States - PDS Tech Commercial, Inc.
Description
PDS Tech Commercial, Inc. is looking for a Sr. Quality Compliance Engineer for our medical device client in Redmond, Washington.Direct Opportunity
Schedule:
First shift, On site preferred, potential for Hybrid
Pay Rate:
$130,000-$140,000 salary
Support medical device reporting assessments and investigations requiring working experience with quality and regulatory standards, including but not limited to FDA 21 CFR Part 820, 21 CFR Part 803, ISO 13485:2016, and ISO Risk Management for Medical Devices).
Requires BS and 5+ yrs. Experience medical device environment
As Sr. Quality Compliance Engineer, you will be responsible for Quality Compliance and Supplier Engineer activities.
You will work closely with several functions including R&D, Regulatory, Clinical, and Operations/Manufacturing in assisting and supporting continuous improvement activities and ensuring compliance with the requirements of the following standards:
ISO 13485, MDSAP, FDA 21 CFR Part 820, MDD, and EU MDR and other applicable standards.
Position Responsibilities :
The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
Sr. Quality Compliance Engineer professionals in Redmond
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Akshata Kumbhar
Quality Engineer | SDET, Test Automation