Biomerics · 11 hours ago
Supplier Quality Engineer
Athens, TX
Full-time
Onsite
Senior Level
5+ years expBiomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. The Supplier Quality Engineer is responsible for ensuring the quality of products received from external suppliers by conducting audits, resolving quality issues, and maintaining strong supplier relationships to improve product quality and compliance with standards.
BiotechnologyHealth CareLaserManufacturingMedical Device
Responsibilities
Supplier evaluation and selection: Assessing potential suppliers through audits and reviews to ensure they meet quality requirements and capabilities
Quality system oversight: Monitoring supplier quality management systems to verify compliance with company standards and industry regulations
Supplier audits: Conducting on-site audits at supplier facilities to evaluate manufacturing processes, quality control procedures, and documentation
Quality issue identification and resolution: Analyzing incoming materials and products to detect defects, performing root cause analysis, and working with suppliers to implement corrective actions
Process improvement: Collaborating with suppliers to identify opportunities for process improvements and implement solutions to enhance product quality
Technical support: Providing technical expertise to suppliers regarding product specifications, quality standards, and testing methods
Advise and support Quality Inspectors on day-to-day issues with incoming materials
Documentation and reporting: Maintaining detailed records of supplier performance, quality issues, corrective actions, and audit findings. Create, issue, and complete Supplier Corrective Action requests
New product introduction support: Working with the engineering team to ensure new suppliers and components meet quality requirements during product development
Supplier performance monitoring: Tracking key performance indicators (KPIs) to evaluate supplier quality and identify areas for improvement
Qualification
Required
High School Diploma or GED required
ASQ / CQE certifications
Six Sigma Certified Green or Black Belt
Strong understanding of quality management systems (QMS) and industry standards
Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, MDD/AIMDD, CMDR, JPAL medical device regulations; Ability to understand other medical device regulations and standards
Experience with statistical analysis tools (e.g., SPC) to identify trends and root causes
Excellent communication and interpersonal skills to effectively collaborate with suppliers and internal teams
Ability to conduct thorough audits and assessments
Problem-solving and analytical skills to identify root causes and implement effective solutions
Proficient in data analysis and report generation
Minimum of 5 years' experience in Quality Engineering within a Medical Device Manufacturing environment
High sense of urgency and commitment to execution
Applies continuous improvement principles in the development of the quality system
Driven, energetic, self-assured professional with high personal integrity
Knowledge of analytical techniques and statistical analysis
Preferred
Experience in nonconforming material and CAPA methodologies/systems preferred
Familiar with Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent)
Company
Biomerics
Biomerics is a medical devices company providing polymer solutions.
1001-5000 employees
H1B Sponsorship
Biomerics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2023-05-17Series Unknown
2023-05-17Acquired
Leadership Team
Arun Mohan
Chief Executive Officer
Recent News
Precedence Research
2025-11-07
2025-10-06
Company data provided by crunchbase