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Full-time
bachelor degree, associate degree
Medical Insurance, Dental Insurance, Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance
Posted 14d ago
~40 hrs/week
Responsibilities
The Quality Engineer will develop and perform inspection activities, monitor data collection systems, and interface with engineering and production teams on new products. They are also responsible for providing guidance to quality lab inspectors and ensuring compliance with customer requirements and quality standards.
Requirements
Candidates must hold an engineering bachelor's degree with 3-5 years of experience, or an associate degree with 5+ years of experience. Proficiency in ISO standards, medical validation, and advanced metrology techniques is required.
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
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.
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.
The leading vertically integrated medical device contract manufacturer serving the interventional device market.
Industry
Medical Equipment Manufacturing
Company size
1,001-5,000 employees
Founded
1994
Headquarters
Salt Lake City, Utah
LinkedIn followers
69,280
Founded in 1994, Biomerics is the leading vertically integrated medical device contract manufacturer serving the interventional device market. Trusted as a vertically integrated partner with extensive engineering expertise and solutions, Biomerics supplies 20 of the top 30 medical device OEMs globally. Biomerics provides engineering design and development services, technology transfer manufacturing services and contract manufacturing services — including sterilization and packaging — for medical device components, subassemblies and finished medical devices. Through nine locations in the United States, two locations in Costa Rica, one in the Dominican Republic and one in Ireland, Biomerics meets customers’ immediate and long-term strategic needs. With comprehensive engineering Centers of Excellence, Biomerics is a leader in materials, interventional medical plastics, complex extrusion, micromachining of metals and polymers, laser processing, guidewires, balloons and balloon catheters, advanced catheters and steerables, image guided intervention, micro-overmolding, micro precision stamping, complex microassembly and finished device assembly. In addition to operating under a certified ISO 13485:2016 quality system, Biomerics is FDA registered and compliant with FDA 21 CFR Part 820.
Markets we serve:
* Cardiovascular
* Endoscopy
* Neuromodulation
* Neurovascular
* Robotic Surgery
* Structural Heart
* Urology
* Vascular Access
Offices: 6030 W Harold Gatty Dr, Salt Lake City, Utah 84116, US
Design EngineeringProduct Transfer EngineeringMaterial Polymerization & Custom CompoundingDevice Coating & DippingMedical ExtrusionInjection MoldingMedical Device AssemblyDevice PackagingSterilization ManagementFulfillment & Distribution
How many Engineering jobs are open in Winston-Salem, NC right now?
There are currently 206 open engineering positions in Winston-Salem, NC listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Winston-Salem, NC?
Companies currently hiring include RTX, ZIEHL-ABEGG Inc. North America, Herbalife, JMT, McAdams, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in Winston-Salem, NC?
Yes — 12 of the 206 open engineering positions offer remote or hybrid work (7 remote, 5 hybrid).
How do I apply for Engineering jobs in Winston-Salem, NC?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.