Advanced Vascular Dynamics
Quality Control Manager
Advanced Vascular Dynamics, Portland, Oregon, United States, 97204
Job Title : Quality Control Manager – Medical Device Manufacturing
Location : Tigard, Oregon
Reports to : Director of Regulatory Affairs
Company:
Advanced Vascular Dynamics (AVD) designs, manufactures and markets an array of non-invasive medical devices used in vascular access procedures.
Job Overview:
The Quality Control (QC) Manager will lead the quality control activities for AVD’s manufacturing operations. This role ensures all products meet regulatory requirements, industry standards, and internal quality specifications. This individual will play a key role in ensuring product safety, efficacy, and compliance with ISO 13485, FDA regulations, and other relevant standards.
Key Responsibilities:
Implement QC systems / Document Control : Oversee the execution of quality control procedures to ensure consistent, high-quality medical device production. Maintain detailed records of quality control activities, product inspections, test results, and non-conformance reports, ensuring all documentation is audit-ready.
Regulatory compliance : Ensure that all quality processes comply with FDA regulations, ISO 13485 standards, and other applicable industry regulations.
Problem-solving and root cause analysis : Investigate product failures or deviations, conducting root cause analysis and implementing corrective and preventive actions (CAPA).
Collaboration and communication : Work closely with cross-functional teams including production, engineering, and regulatory affairs to address quality concerns and drive continuous improvement.
Supplier quality management : Collaborate with procurement and supply chain teams to establish quality requirements and perform regular supplier audits.
Training and development : Provide training to production and QC staff on quality standards, inspection techniques, and regulatory updates.
Qualifications:
Education : Bachelor’s degree in Engineering, Life Sciences, or a related field. Master’s degree is a plus.
Experience : Minimum of 3 years of experience in quality control or quality assurance within a regulated environment. Understanding of FDA regulations (21 CFR Part 820), ISO 13485, and other relevant standards a plus. Proficiency in quality tools and methodologies such as Six Sigma, Lean Manufacturing, and CAPA processes.
Skills:
Strong attention to detail and a methodical approach to quality control.
Ability to foster a culture of quality and continuous improvement.
Proficient in MS Office programs.
Excellent problem-solving and analytical skills.
Exceptional written and verbal communication skills.
Strong collaboration and interpersonal skills.
Job Types:
Full-time, Part-time
Pay:
$80,000.00 - $90,000.00 per year
Benefits:
Dental insurance
Flexible schedule
Health insurance
Paid time off
Retirement plan
Schedule:
8 hour shift
Monday to Friday
Weekends as needed
Work Location:
In person
#J-18808-Ljbffr
Location : Tigard, Oregon
Reports to : Director of Regulatory Affairs
Company:
Advanced Vascular Dynamics (AVD) designs, manufactures and markets an array of non-invasive medical devices used in vascular access procedures.
Job Overview:
The Quality Control (QC) Manager will lead the quality control activities for AVD’s manufacturing operations. This role ensures all products meet regulatory requirements, industry standards, and internal quality specifications. This individual will play a key role in ensuring product safety, efficacy, and compliance with ISO 13485, FDA regulations, and other relevant standards.
Key Responsibilities:
Implement QC systems / Document Control : Oversee the execution of quality control procedures to ensure consistent, high-quality medical device production. Maintain detailed records of quality control activities, product inspections, test results, and non-conformance reports, ensuring all documentation is audit-ready.
Regulatory compliance : Ensure that all quality processes comply with FDA regulations, ISO 13485 standards, and other applicable industry regulations.
Problem-solving and root cause analysis : Investigate product failures or deviations, conducting root cause analysis and implementing corrective and preventive actions (CAPA).
Collaboration and communication : Work closely with cross-functional teams including production, engineering, and regulatory affairs to address quality concerns and drive continuous improvement.
Supplier quality management : Collaborate with procurement and supply chain teams to establish quality requirements and perform regular supplier audits.
Training and development : Provide training to production and QC staff on quality standards, inspection techniques, and regulatory updates.
Qualifications:
Education : Bachelor’s degree in Engineering, Life Sciences, or a related field. Master’s degree is a plus.
Experience : Minimum of 3 years of experience in quality control or quality assurance within a regulated environment. Understanding of FDA regulations (21 CFR Part 820), ISO 13485, and other relevant standards a plus. Proficiency in quality tools and methodologies such as Six Sigma, Lean Manufacturing, and CAPA processes.
Skills:
Strong attention to detail and a methodical approach to quality control.
Ability to foster a culture of quality and continuous improvement.
Proficient in MS Office programs.
Excellent problem-solving and analytical skills.
Exceptional written and verbal communication skills.
Strong collaboration and interpersonal skills.
Job Types:
Full-time, Part-time
Pay:
$80,000.00 - $90,000.00 per year
Benefits:
Dental insurance
Flexible schedule
Health insurance
Paid time off
Retirement plan
Schedule:
8 hour shift
Monday to Friday
Weekends as needed
Work Location:
In person
#J-18808-Ljbffr