Senior Account Executive (saas)

This Jobot Job is hosted by: Amanda Preston

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Salary: $110,000 - $135,000 per year

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.

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

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

Interested in hearing more? Easy Apply now by clicking the "Apply" button.

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