Quality Assurance Engineer - Medical Devices
Title: Quality Assurance Engineer - Medical Devices
Job Summary:
A fast-growing medical technology company is seeking a Quality Assurance Engineer to join their team and support the development and manufacturing of advanced medical devices. This role is ideal for someone who thrives in a documentation-heavy environment, enjoys problem-solving, and has a strong background in regulated industries. The ideal candidate will bring a passion for quality systems, a sharp analytical mindset, and a collaborative spirit.
As a Quality Assurance Engineer, you will:
- Lead and support investigations into nonconforming materials and components, including root cause analysis and corrective/preventive actions (CAPAs)
- Develop and maintain validation documentation including protocols, plans, and reports
- Participate in cross-functional meetings to support product development and design transfer
- Review and approve quality documentation such as inspection records, material reports, and manufacturing specifications
- Assist in supplier quality activities and internal audits
- Ensure compliance with applicable regulatory standards and internal procedures
- Contribute to continuous improvement initiatives and risk-based decision-making processes
What you bring to the table:
- 3-5 years of experience in a quality role within the medical device industry
- Strong understanding of CAPA processes, root cause analysis tools, and validation practices
- Familiarity with FDA 21 CFR Part 820 and ISO 13485 standards
- Excellent technical writing skills and attention to detail
- Experience with electro-mechanical assembly, cleanroom protocols, or sterilization processes is a plus
- Proficiency in Microsoft Office; experience with statistical tools like Minitab is desirable
- Must be a U.S. person (citizen or permanent resident)
Compensation & Perks:
- Base salary targeted around the mid to high $90Ks, with potential flexibility for exceptional candidates
- 10% annual performance bonus
- Opportunities for growth and visibility within a collaborative, innovation-driven team
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.