Job Description
This Jobot Job is hosted by: Amanda Preston
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Salary: $110,000 - $135,000 per year
A bit about us:
We are a growing, quality-driven manufacturer specializing in medical device and combination product production. Our team is committed to delivering safe, reliable, and compliant products that make a meaningful impact on patient care.
With a strong foundation in regulated manufacturing, we focus on continuous improvement, operational excellence, and innovation across our processes. We pride ourselves on maintaining a collaborative, hands-on environment where employees are empowered to contribute, develop their skills, and take ownership of their work.
Why join us?
Clean, climate-controlled environment with a strong emphasis on quality and safety
Stable schedule that supports work-life balance
Competitive compensation and comprehensive benefits package
Health, dental, and vision insurance
401(k) with company contribution
Paid holidays and generous PTO
Tuition reimbursement and ongoing training opportunities
Clear paths for career growth and advancement
Supportive leadership and a team-oriented culture
Job Details
We are seeking a highly skilled Quality Engineer with experience in medical device, combination products, or Assembly, Labeling, and Packaging (ALP) manufacturing. This role is critical to ensuring product quality, regulatory compliance, and operational excellence across the full manufacturing lifecycle.
You will play a key role in sustaining engineering efforts, continuous improvement initiatives, and the execution of quality systems, partnering closely with cross-functional teams across operations, engineering, and regulatory.
Responsibilities
Provide Quality Engineering support for medical device operations, combination products, and ALP manufacturing lines
Ensure compliance with FDA regulations, including 21 CFR Part 820, and applicable ISO standards such as ISO 13485 and ISO 14971
Support and lead risk management activities, including FMEA and product risk assessments
Oversee processes related to sterile barrier packaging, labeling control systems, and drug-device interface considerations
Lead or support investigations, root cause analysis, CAPA, and nonconformance resolution
Collaborate with cross-functional teams to drive process improvements, validation activities, and product lifecycle support
Assist with internal audits, external audits, and regulatory inspections
Drive continuous improvement initiatives focused on quality, efficiency, and compliance
Qualifications
5+ years of experience in medical device quality engineering, combination products, or ALP manufacturing
Experience with assembly operations, packaging, and labeling processes in a regulated environment
Knowledge of sterile barrier packaging, labeling control systems, or drug-device interface requirements
Strong understanding of FDA QSR, ISO 13485, ISO 14971, and applicable regulatory frameworks
Experience with risk management tools such as FMEA
Strong analytical, problem-solving, and communication skills
Bachelor’s degree in Engineering or a related field
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