Senior Account Executive (saas)
Jobot
Job Description
This Jobot Job is hosted by: Amanda Preston Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. 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
Interested in hearing more? Easy Apply now by clicking the "Apply" button.
Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy