Biomerics · 2 months ago
Quality Control 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 Quality Control Engineer will provide Quality Engineering input to support Medical Device Manufacturing and lead Quality Assurance initiatives to ensure compliance with regulatory requirements and improve product quality. Responsibilities include managing validation activities, supporting engineering efforts, and driving continuous improvement initiatives.
BiotechnologyHealth CareLaserManufacturingMedical Device
Responsibilities
Lead Quality Assurance in support of manufacturing activities in accordance with the requirements of USFDA CFR 820, ISO 13485, and MHLW Ministerial Ordinance 169
Manage validation activities as established by USFDA CRF 820, ISO 13485, MHLW Ministerial Ordinance 169, and other regulatory bodies as required
Support engineering efforts by developing, implementing, and maintaining quality requirements and standards throughout the design transfer and manufacturing of products
Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints), leading or participating in efforts and cross-functional teams focused on identifying the primary root causes and implementing corrective and preventative actions
May be responsible for creating risk analyses and FMEAs
Collects and analyzes process defect date for product/process improvement efforts (e.g., scrap, nonconforming product, customer complaints) by systematically gathering metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development
Owns and drives Nonconforming Event and Correction and Preventative Action investigations
Supports continuous improvement activities, NCEPs, CAPA, and Lean initiatives
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Support internal and external regulatory audits
Qualification
Required
Bachelor's Degree in Engineering, Biomedical Engineering, or related science discipline
ASQ / CQE certifications
Six Sigma Certified Green or Black Belt
Minimum of 5 years' experience in Quality Engineering within a Medical Device Manufacturing environment
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
Familiar with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent)
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
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