Sr. Quality Compliance Engineer
Company: PDS Tech Commercial, Inc.
Location: Redmond
Posted on: May 3, 2024
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Job 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 HybridPay Rate: -$130,000-$140,000
salarySupport 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 14971 (Risk
Management for Medical Devices).Requires BS and 5+ yrs. Experience
medical device environmentAs 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:---
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 14971 (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.Position Qualifications: --- 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. -Pay Details: $130,000.00 to $140,000.00 per year Equal
Opportunity Employer/Veterans/DisabledTo read our Candidate Privacy
Information Statement, which explains how we will use your
information, please navigate to
https://www.pdstech.com/candidate-privacy /> The Company will
consider qualified applicants with arrest and conviction records
subject to federal contractor requirements and/or security
clearance requirements.
Keywords: PDS Tech Commercial, Inc., Seattle Hill-Silver Firs , Sr. Quality Compliance Engineer, Engineering , Redmond, Washington
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