Overview
Quality Control Inspector Jobs in Milwaukie, OR at American Precision Industries
Must have experience working with an In Vitro Diagnostics (IVD) Devices in a manufacturing environment!
Position: Director of Quality Assurance with FDA and In Vitro Diagnostics (IVD) devices. (IVD)
Full-Time Direct Hire Salary
Client Location: Toronto, Ontario Canada area
50% Remote from Home and 2 weeks month onsite in Toronto Canada area
**** Client is looking to interview ASAP!
Our direct client is looking for a Director of Quality Assurance (IVD & FDA) that has a background with In Vitro Diagnostics (IVD) devices.
The Client is open to candidates located in Canada or based in the United States. client will pay travel expenses.
Travel Requirement:
Must be able to travel to Toronto, Canada, 50% of the time (client covers travel expenses).
50% Remote from Home and 2 weeks month onsite in Toronto Canada area
Our client, an innovative and well-funded IVD company, is seeking a Director of Quality Assurance with expertise in In Vitro Diagnostics (IVD) devices and FDA compliance. This leader will oversee and grow the company’s QMS, ensuring alignment with global regulations (Health Canada, FDA, EU) as they prepare for clinical trials and product launch in 2025.
Key Responsibilities:
Lead the development and implementation of the Quality Management System (QMS) from development to commercial operations.
Ensure compliance with Health Canada, FDA, EU regulations, and corporate policies across assays, consumables, instrumentation, and manufacturing.
Manage and mentor a growing QA team, driving a quality-first mindset across the organization.
Oversee new product development, including R&D, prototyping, clinical trials, validation, and commercialization.
Lead and prepare the organization for ISO 13485 audits, managing CAPAs and non-conformances.
Collaborate cross-functionally with product development, manufacturing, and operations teams.
Education:
Bachelor’s degree in Science, Engineering, or a related field. Advanced degree preferred.
Experience:
Must have hands on experience working with an In Vitro Diagnostics (IVD) company in Quality Assurance
At least 2 years of Hands on working experience with In Vitro diagnostic (IVD) devices.
Min 5 years of Management with at least 5 direct reports
Min 2 years of Director Level experience (including some hands on)
10 + years of overall experience in Quality Assurance within Life Science Industry (pharmaceutical, biotechnology, medical devices, or In Vitro Diagnostics (IVD) Industry)
Strong experience with QMS Systems including implementation or the build out of a QMS System
Must have experience with any type of New Product/Device from ideation to full product launch
Has led an organization through an ISO 13485 audit
Extensive cGMP and regulatory experience
Strong knowledge of quality management practices, cGMPs, and current trends in quality and regulatory compliance, especially across reagents/chemistry, consumables, and instrumentation
Working in a startup, understanding Change Control Lite – Nice to have
Exceptional organizational and leadership abilities, with a proven track record in quality assurance management. Strong communication skills for effective debate, persuasion, and collaboration
Experience managing reams, hands on managers, grow, mentor, coach and guide
Travel Requirement:
Must be able to travel to Toronto, Canada, 50% of the time (client covers travel expenses).
Nice to have
Gone though all phases:
Phase 1 – R&D
Phase 2 – Prototype
Phase 3 – Clinical Trials
Phase 4 – V & V – Verification and Validation
Phase 5 – Commercial Launch
A well funded, early stage in vitro diagnostics (IVD) company is seeking an energetic leader to manage and lead its quality assurance efforts. Specifically, the company is exiting Phase 2 of its product develop process and readying for clinical trials in 2025 for its multi-analyte POC instrument system and reagents. The QA team is currently small but is expected to evolve and grow within the coming year, led by this individual. Our client is seeking an organized and energetic individual to lead the company in implementing our Quality Management System (QMS) and embracing a quality mindset. As the Head of Quality Assurance, you will lead the company’s QMS, ensuring rigorous compliance with global standards and driving a strategic approach to quality. You will implement, monitor, and continuously improve quality assurance processes, aligning with Health Canada, FDA, and EU regulations and corporate policies. This position will provide oversight across the full product lifecycle, from development to commercial operations, supporting teams in assay, consumable, instrumentation, manufacturing, and operations.
Benefits:
Paid time off
Monday to Friday schedule
Full-time, permanent position
Professional Reference Check will be required!
If you have the expertise to drive quality assurance excellence in the IVD industry and meet the qualifications, apply now with your Word resume, phone number, and email.
Please note, I am based in the USA, Eastern Time Zone.
Job Type: Full-time
Pay: $175,000.00 – $255,000.00 per year
Benefits:
Paid time off
Schedule:
Monday to Friday
Education:
Bachelor’s (Required)
Experience:
Director of QA: 3 years (Required)
Quality assurance: 10 years (Required)
In Vitro Diagnostics (IVD) devices.: 3 years (Required)
ISO 13485: 3 years (Required)
Life Sciences (Pharma, Biotech, Med device): 10 years (Required)
Quality Management System (QMS): 5 years (Required)
cGMP: 5 years (Required)
FDA regulations: 6 years (Required)
Willingness to travel:
50% (Required)
Work Location: Hybrid remote in Raritan, NJ 08869
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Title: Quality Control Inspector
Company: American Precision Industries
Location: Milwaukie, OR
