Quality Engineer

BIOMERICS LLC

• 3.

0 Winston-Salem, NC Job Details Full-time 13 hours ago Benefits Paid holidays Disability insurance Health insurance Dental insurance 401(k) Vision insurance Life insurance Qualifications Statistics Process flow diagrams Measurement-based inspection Customer communication Microsoft Excel Production data analysis Defect resolution root cause analysis Machine vision systems Safety protocol adherence Procedural guides Quality control statistical data analysis Preventive action implementation Statistical Process Control Corrective and preventive actions (CAPA) Dimensional measurements Parts drawings Production validation processes Customer engagement Biomedical regulatory compliance Productivity software PPAP Quality improvement programs in engineering

ISO 13485

Data analysis software

Full Job Description 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 our employees' lives and the lives of the patients who depend on our products. At Biomerics, we are guided by our core values of integrity, partnership, empowerment & accountability, trust, agility, teamwork, and excellence. We deeply care about our team members and customers, and our team-oriented, customer-focused corporate culture places a premium on building strategic, mutually beneficial partnerships. Joining our team means becoming part of a dynamic, innovative, and caring community.

JOB SUMMARY

Supplement the Quality aspects of the organization. Participate in quality improvements of the company. Give direction to production personnel as to Customer expectations and requirements for products. Interface with Customers for concerns, process changes, etc. Train production and other Quality personnel on use of inspection equipment. Develop and perform inspection activities per customer and internal requirements. Setup and monitor data collection systems. Interface with Engineering and Production on new products and product lines. Perform Part/Assembly qualification activities. Develop necessary metrology techniques and fixtures to support part measurement. Develop performance characterizations such as force testing, gap testing, continuity tests, hi-pot tests etc.

ESSENTIAL FUNCTION

On-site regular and reliable attendance is required. Provide guidance and direction to Quality Lab Inspectors and Technicians as necessary for dimensional, visual, and other features as detailed per the design.

ADDITIONAL RESPONSIBILITIES

As determined by the Director of Quality.

KNOWLEDGE, SKILLS, AND ABILITIES

In-depth knowledge of manufacturing processes, Injection Molding, Metal Stamping, & Assembly Engineering bachelor's degree and 3-5 years Quality experience, or associate degree with 5+ years Quality experience, or minimum 10 years quality experience. Must be goal oriented, with strong interpersonal skills, continuous improvement skills, quality inspection skills, customer communication skills, and continuous improvement skills. If selection is internal have demonstrated solid product knowledge Must work safely at all times

Requirements:

Should have specific training and working knowledge in the following areas:

ISO 9001

2015 and

ISO 13485

2016 Medical Validation

• IQ, OP, PQ

  Experience
• Protocols PPAP
• Production Part Approval Process APQP

• Advanced Product Quality Planning Core Documents:

  Control Plans, PFMEA, Flow Diagrams, Work Instructions, & Inspection Instructions GR&R
• Gage Repeatability & Reproducibility MSA
• Measurement System Analysis CAPA
• Corrective Action / Preventive Action Advanced Problem-Solving Techniques
• 8D, 3L5Y, Fishbone Metrology Experience

•

OGP / QVI

/ Optical Comparator / CMM / Keyence Vision System & Handheld Equipment Print Reading /

Advanced GD&T Experience Strong Microsoft Office Knowledge:

Excel, Word, PowerPoint SPC

• Statistical Process Control and evaluation Data Analytical Skills
• Minitab Software Why Join Biomerics?

At Biomerics, you will be part of a collaborative and growth-oriented organization dedicated to improving lives through innovation and manufacturing excellence. We value individuals who are passionate about building strategic customer partnerships and driving operational and commercial success within the medical device industry.

Benefits:

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