Quality Control Engineer

Responsibilities

• Perform Quality Assurance and Quality Control in support of manufacturing activities in accordance with the requirements of USFDA CFR 820 and ISO 13485.
• 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.
• Collects and analyzes process defect data for product/process improvement efforts (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s).
• Owes and drives Nonconforming Event and Correction and Preventive Action investigations.
• Supports continuous improvement activities, NCMRs, CAPA, and Lean initiatives.
• Supports engineering efforts by developing, implementing, and maintaining quality requirements and standards throughout the transfer and manufacturing of products.
• Responsible for creating control plans and risk analyses (PFMEAs).
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Requirements

• Bachelor's Degree in Engineering, Biomedical Engineering, or related science discipline.
• Minimum of 3 years' experience in Quality Engineering within a Medical Device Manufacturing environment for a company in a regulated industry (IVD, pharmaceuticals, medical device, biologics, etc.).
• ASQ CQE certification is a plus.
• Six Sigma Certified Green or Black Belt is a plus.
• Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, MDD/AIMDD, CMDR; Ability to understand other medical device regulations and standards.
• Experience in nonconforming material and CAPA methodologies/systems preferred.
• Strong communication, presentation, facilitation, and project management skills.
• Experience working in cross-functional teams and driving projects to completion.
• 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.
• Ability to develop effective, positive interpersonal relationships.

Qualifications

Biomerics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.