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BM
BIOS Medical
Lead Quality Assurance Engineer
Job Description
Overview We are seeking a dedicated and detail-oriented Quality Assurance engineer to join our team. In this role, you will be responsible for overseeing the day to day quality assurance processes to ensure that our products meet the highest standards of quality and compliance with industry regulations. Responsible for all CAPA investigation, Customer Complaint Investigations, Metrology Calibration and Control. You will play a crucial role in maintaining our commitment to continuous improvement within our manufacturing operations. Responsibilities Develop, implement, and maintain quality control systems in accordance with
ISO 13485
standards. Conduct regular quality inspections and audits to ensure compliance with FDA regulations and internal policies. Analyze data from quality inspections to identify trends and areas for improvement. Collaborate with production teams to fabricate processes that enhance product quality and efficiency. Lead project management initiatives related to quality assurance improvements and corrective actions. Train and mentor staff on QA/QC procedures, ensuring adherence to best practices in quality control. Prepare detailed reports on quality metrics, inspection results, and audit findings for management review. Facilitate communication between departments regarding quality issues and resolutions. Qualifications Bachelor's degree in a relevant field such as Engineering, Manufacturing, or Quality Assurance. Proven experience in quality, within a manufacturing environment Strong knowledge of FDA regulations, ISO 13485 standards, and quality assurance methodologies. Proficiency in conducting quality audits and inspections with a keen eye for detail. Excellent analytical skills with the ability to interpret complex data sets. Strong project management skills with a track record of leading successful initiatives. Effective communication skills, both verbal and written, with the ability to work collaboratively across teams. Certification in Quality Management or related fields is a plus. Medical Device Experience is a plus. Join us in our mission to deliver exceptional products while fostering a culture of quality and continuous improvement!Job Type:
Full-time Benefits:
Dental insurance Flexible schedule Health insurance Paid time off Vision insuranceExperience:
FDA regulations: 1 year (Required)ISO 13485
2 years (Required) Ability toCommute:
Nesbit, MS 38651 (Preferred) Ability toRelocate:
Nesbit, MS 38651: Relocate before starting work (Required)Work Location:
In personBenefits
- Paid Time Off (PTO)
- Flexible Work Schedules
- Health Insurance
- Dental Insurance
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Based on Mississippi data
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What they do
A Quality Assurance Manager focuses on prevention of mistakes and defects in manufacturing products. Develops procedures to ensure that quality standards are maintained. Manages all steps related to quality assurance as part of the quality management strategy of a company. May involve leadership of a team of quality assurance supervisors, specialists, and other associated staff members.
$100,430 / year median in Mississippi
+3% projected growth