Quality Engineer I

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 deeply committed to our diverse employee base. We recognize that a strong, skilled, and engaged workforce is the bedrock of our continued success as a business. We strive to embody the Biomerics values in all our interactions. Joining our team at this exciting time means being part of a community that truly values and invests in its employees, with no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and the 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.

Job Description

As a Quality Engineer at Biomerics, you will be crucial in providing Quality Engineering input to support Medical Device Manufacturing, Manufacturing Engineering, Operations, and Distribution activities. Your responsibilities will include developing, establishing, and maintaining quality engineering methodologies, systems, and practices that meet Biomerics, customer, and regulatory requirements. You will serve as a Quality representative, improving awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional, and corporate quality goals and priorities. Your work may also involve supporting new product development (NPD) as needed. In essence, you will be leading Quality Assurance (QA) in support of manufacturing activities in accordance with the requirements of USFDA CFR 820, ISO 13485, and MHLW Ministerial Ordinance 169, making a significant impact on our operations and the quality of our products.

Description Of 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 product design transfer and manufacturing.
• 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.
  
  

Requirements

• Bachelor’s Degree in a STEM field.
• A minimum of 3 years' experience in Engineering within a Medical Device Manufacturing environment for a company in a regulated industry (IVD, pharmaceuticals, medical devices, biologics, etc.) is required. Quality Engineering is preferred but not a must. All engineering fields will be considered.
• ASQ CQE certifications 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, JPAL medical device regulations; 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.
• Familiarity 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.
• Knowledge of analytical techniques and statistical analysis.
• Ability to develop effective, positive interpersonal relationships.
  
  

Benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k.

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 does not accept non-solicited resumes or candidate submittals from search/recruiting agencies that are 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, and if Biomerics subsequently hire the candidate, Biomerics shall not owe any fee to the submitting agency.