Quality Engineer

Biomerics; Winston-Salem (NC); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical/Dental/Vision Insurance

Short-Term Disability

Long-Term Disability

Life Insurance

Paid Vacation Days

Paid Holidays

401k

Job summary

Biomerics is seeking an experienced Quality Engineer to advance quality initiatives by developing inspection, testing, and qualification activities aligned with customer and internal requirements. You will collaborate with Engineering, Production, and customers to resolve quality concerns and support new product introductions while ensuring compliance with design specifications.

You will develop metrology techniques, measurement fixtures, and data collection systems to drive continuous

Qualifications

• Engineering bachelor’s degree required or equivalent experience.
• 3–5 years quality experience (or 5+ with associate degree) or 10 years quality experience.
• ISO 9001:2015 and ISO 13485:2016 knowledge.
• Experience with PPAP, APQP, CAPA; PFMEA; Control Plans.
• Metrology experience with CMMs, optical comparators, and vision systems.
• Strong data analysis skills using Minitab and MS Office.

Responsibilities

• Support quality initiatives and improvements across the organization.
• Collaborate with Engineering, Production, and Customers to address quality concerns.
• Provide training on inspection methods and equipment to staff.
• Develop and qualify parts/assemblies per customer and internal requirements.
• Set up and monitor data collection systems for quality metrics.
• Interface with Engineering and Production on new products and lines.
• Lead part/assembly qualification activities and metrology challenges.
• Support testing such as force, gap, continuity, and hipot tests.

Skills

Quality engineering

Inspection methods

Customer communication

Continuous improvement

Statistical analysis

Education

Bachelor’s degree in Engineering

Associate degree with 5+ years quality experience

10+ years quality experience

Tools

CMM

Optical Comparator

Keyence Vision System

OGP / QVI

Minitab

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:

Biomerics is seeking an experienced Quality Engineer to support and enhance organizational quality initiatives by developing and executing inspection, testing, and qualification activities that meet customer and internal requirements. Collaborate with Engineering, Production, and customers to address quality concerns, support new product introductions, and ensure product compliance with design specifications. Develop metrology techniques, measurement fixtures, and performance testing methods, while establishing and monitoring data collection systems to drive continuous improvement. Provide technical guidance and training to Quality Lab Inspectors, Technicians, and production personnel on inspection methods, equipment, and customer quality expectations. Perform part and assembly qualifications and support testing such as force, gap, continuity, and high-potential (hipot) testing.

• 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.

Requirements

• 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 timesISO 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.