Quality Engineer II

Job Type

Full-time

Description

Company Overview

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and patients who depend on our products.

At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.

Responsibilities:

• The Quality Engineer II supports operations to ensure that devices, components, and materials are produced to meet customers' expectations and comply with Biomerics SOPs.
• Additionally, the QE will support new product development (NPD) activities.
• Lead Quality Control supporting manufacturing activities per USFDA CFR 820 and ISO 13485 requirements.
• 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.
• Owns and drives Nonconforming Event and Correction and Preventive Action investigations.
• 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) to enhance sustaining product design and new product development.
• Manage validation activities to support Manufacturing and Design activities.
• Support engineering efforts by developing, implementing, and maintaining quality requirements and standards throughout product design transfer and manufacturing.
• May be responsible for creating risk analyses and FMEAs.
• Manage projects and/or provide project support from the Quality function.
• Interact effectively with customers, suppliers, and internal resources.
• 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.
• A minimum of 3 years’ experience in Quality Engineering within a Medical Device Manufacturing environment for a company in a regulated industry (IVD, pharmaceuticals, medical devices, biologics, etc.) is required.
• Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, MDD/AIMDD, CMDR; Ability to understand other medical device regulations and standards.
• 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.
• Ability to work independently.
• Understand Lean Principles and Techniques.
• Can execute Gap Analysis’ of manufacturing lines to ensure compliance.
  
  

Biomerics offers the following benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, 9 Paid Holidays, 401k, Onsite Fitness Facility.

Please, No Recruitment Agency calls or emails (we are not using recruitment services for this or any other role posted).

The salary estimates are estimates from this job board and not a guarantee from Biomerics' salary range.

Biomerics only accepts non-solicited resumes or candidate submittals from search/recruiting agencies not already on Biomerics approved agency list. Unsolicited resumes or candidate information submitted to Biomerics by search/recruiting agencies not already on Biomerics approved agency list shall become the property of Biomerics. If Biomerics subsequently hires the candidate, Biomerics shall not owe any fee to the submitting agency.