Quality Engineer

Salt Lake, UT - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Description:
We are seeking a Quality Engineer with experience in the medical device industry to support quality assurance regulatory compliance and continuous improvement initiatives. The ideal candidate will have a strong background in FDA regulations ISO 13485 risk management (ISO 14971) and product lifecycle management including design control and CAPA systems.
Responsibilities:

Ensure compliance with FDA 21 CFR Part 820 ISO 13485 and other applicable regulatory standards.
Support design control activities including design verification/validation risk analysis (FMEA FTA) and product release.
Develop and maintain quality documentation including SOPs work instructions inspection plans and validation protocols.
Perform root cause investigations and drive Corrective and Preventive Actions (CAPA) to resolution.
Conduct or support internal audits supplier audits and regulatory inspections.
Monitor and improve product quality metrics (yield complaints non-conformances etc.).
Collaborate with cross-functional teams (R&D Manufacturing Regulatory Supply Chain) to ensure quality is built into processes and products.
Lead or assist in supplier quality management activities including qualifications audits and performance monitoring.
Participate in risk management processes and ensure appropriate risk controls are implemented.
Support changing control processes for product or process changes.
Contribute to continuous improvement initiatives using tools such as Six Sigma Lean and 8D.

Requirements:

Bachelors degree in engineering Life Sciences or related field.
2 5 years of quality engineering experience in the medical device or regulated industry.
Strong knowledge of FDA QSR (21 CFR Part 820) and ISO 13485.
Experience with risk management (ISO 14971) and design control practices.
Hands-on experience with CAPA Company validations (IQ/OQ/PQ) and audits.
Proficient in quality tools such as FMEA 8D Root Cause Analysis etc.
Excellent analytical documentation and communication skills.

Job Description: We are seeking a Quality Engineer with experience in the medical device industry to support quality assurance regulatory compliance and continuous improvement initiatives. The ideal candidate will have a strong background in FDA regulations ISO 13485 risk management (ISO 14971) and ...

Ensure compliance with FDA 21 CFR Part 820 ISO 13485 and other applicable regulatory standards.
Support design control activities including design verification/validation risk analysis (FMEA FTA) and product release.
Develop and maintain quality documentation including SOPs work instructions inspection plans and validation protocols.
Perform root cause investigations and drive Corrective and Preventive Actions (CAPA) to resolution.
Conduct or support internal audits supplier audits and regulatory inspections.
Monitor and improve product quality metrics (yield complaints non-conformances etc.).
Collaborate with cross-functional teams (R&D Manufacturing Regulatory Supply Chain) to ensure quality is built into processes and products.
Lead or assist in supplier quality management activities including qualifications audits and performance monitoring.
Participate in risk management processes and ensure appropriate risk controls are implemented.
Support changing control processes for product or process changes.
Contribute to continuous improvement initiatives using tools such as Six Sigma Lean and 8D.

Requirements:

Bachelors degree in engineering Life Sciences or related field.
2 5 years of quality engineering experience in the medical device or regulated industry.
Strong knowledge of FDA QSR (21 CFR Part 820) and ISO 13485.
Experience with risk management (ISO 14971) and design control practices.
Hands-on experience with CAPA Company validations (IQ/OQ/PQ) and audits.
Proficient in quality tools such as FMEA 8D Root Cause Analysis etc.
Excellent analytical documentation and communication skills.