Quality Control Engineer
Quality Control Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
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 youre seeking a role where your input matters your expertise is valued and your impact is visible across the organization we encourage you to apply.
Employment Type
Full Time
