Quality Control Engineer

Company : KeyPoint Staffing

Opportunity for a Quality-Focused Engineer in Medical Manufacturing
Our client is currently hiring a Quality Assurance Engineer to join their growing operations in the medical device sector. This full-time role is perfect for a mid-level professional with 3 to 5 years of relevant experience who enjoys collaborating across teams and ensuring excellence in product quality, compliance, and manufacturing support.

This position plays a key role in maintaining high standards across the production and product development lifecycleensuring all activities meet applicable regulatory and internal quality standards.

What Youll Take Ownership Of:

• Drive material review activities and help lead weekly meetings focused on nonconformance evaluation and resolution
• Follow up on vendor quality issues and coordinate disposition efforts
• Maintain calibration tracking systems to support precision in equipment usage
• Work closely with manufacturing engineers to develop and update documentation such as build records, process flows, BOMs, and manufacturing instructions
• Assist with transitioning new products from R&D into production environments
• Perform component-level reviews for incoming materials to verify conformance
• Write and update standard operating procedures, inspection criteria, and lab test methods
• Ensure all documentation and activities align with applicable regulations and company policies
• Support quality investigations involving customer complaints, internal deviations, and CAPA execution
• Participate in internal audits and supplier performance evaluations
• Apply structured problem-solving techniques to assess root causes and support corrective/preventive efforts
• Use data-driven analysis to recommend and implement risk-based quality decisions

Who Were Looking For:

• 3-5 years of hands-on quality experience in a regulated medical manufacturing environment
• Solid understanding of FDA 21 CFR Part 820 and ISO 13485 standards
• Prior experience executing and managing CAPA programs
• Exposure to incoming inspection, cleanroom practices, and electro-mechanical or cable assembly preferred
• Knowledge of validation protocols, including equipment, process, and test method validations (including Gage R&R)
• Comfortable using Microsoft Office Suite; proficiency in Excel is especially important
• Working familiarity with statistical analysis tools and methods; Minitab experience is a plus
• Excellent technical writing skills for protocol development and formal reporting
• Experience working in a start-up or early-phase company is a bonus

This Role Is a Fit If You:

• Thrive in a collaborative team environment
• Can manage multiple priorities with attention to detail
• Enjoy troubleshooting and using data to guide decisions
• Are driven to maintain the highest standards in product quality and compliance

If you're seeking a role where your input matters, your expertise is valued, and your impact is visible across the organization, we encourage you to apply.

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