What are the responsibilities and job description for the Quality Engineer position at Jobot?
Job Details
Competitive Compensation & Benefits. Growth Opportunity. 401k match. Tuition Reimbursement.
This Jobot Job is hosted by: Brooke Meyer
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $55,000 - $80,000 per year
A bit about us:
We are a leading provider of contract manufacturing solutions to customers in search of the best medical device manufacturers.
Why join us?
Job Details
The Quality Engineer will be instrumental in ensuring our devices meet all regulatory standards and company requirements. This role will design, execute, and document validation processes to support the development and manufacturing of products. The role will be critical in maintaining our commitment to delivering safe, reliable, and high-quality medical devices that improve patient outcomes.
Responsibilities:
Requirements:
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
This Jobot Job is hosted by: Brooke Meyer
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $55,000 - $80,000 per year
A bit about us:
We are a leading provider of contract manufacturing solutions to customers in search of the best medical device manufacturers.
Why join us?
- Competitive Base Salary!
- Excellent Benefits Package!
- Flexible Work Schedules!
- Accelerated Career Growth!
- Benefit Eligibility is immediate, enroll on day one of employment
- Robust 401k plan with 3% employer contribution, no minimum employee contribution required
- 9 Paid Holidays and Paid Vacation time
- Health / Dental / Vision Insurance
- Short / Long-Term Disability Insurance
- Professional development assistance
- Tuition reimbursement, and more!
Job Details
The Quality Engineer will be instrumental in ensuring our devices meet all regulatory standards and company requirements. This role will design, execute, and document validation processes to support the development and manufacturing of products. The role will be critical in maintaining our commitment to delivering safe, reliable, and high-quality medical devices that improve patient outcomes.
Responsibilities:
- Develop and implement validation plans for new and existing products, considering design, manufacturing processes, equipment, and software in compliance with FDA regulations and ISO standards.
- Coordinate with Engineering, manufacturing, and quality teams to establish requirements and standards for validation activities.
- Execute validation tests including but not limited to design validation, process validation, software validation, and test method validation.
- Prepare, review, and approve validation documents, including protocols, reports, and risk assessments.
- Ensure that all validation activities are conducted in accordance with internal procedures and regulatory requirements.
- Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
- Provide technical support for troubleshooting and resolving validation issues encountered during production or testing.
- Stay current with industry standards, regulatory requirements, and advancements in technology and apply them to validation practices.
- Collaborate with cross-functional teams to facilitate changes or improvements in manufacturing processes, product design, and quality assurance methods.
- Assist in the development and implementation of training programs related to validation processes and procedures.
Requirements:
- Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related field).
- Minimum of 3 years of experience in validation engineering within the medical device industry.
- In-depth knowledge of FDA regulations, including QSR and ISO 13485, as well as other international standards relevant to medical device manufacturing.
- Strong understanding of validation principles, including design, process, and software validation.
- Experience with statistical analysis tools and methodologies.
- Excellent problem-solving, analytical, and organizational skills.
- Strong communication and teamwork skills, with the ability to work effectively in cross-functional teams.
- Ability to manage multiple projects simultaneously and meet deadlines.
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
Salary : $55,000 - $80,000
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