
Website KeyPoint Staffing
KeyPoint Staffing
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.