Biomerics

Quality Control Engineer

Biomerics  •  Winston, FL / Salem, OR (Onsite)  •  15 days ago
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Job Description

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 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 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.

The Quality Engineer supplements the quality aspects of Biomerics by participating in quality improvements, communicating customer expectations to production personnel, and performing various inspection and qualification activities. This role involves direct interaction with customers, internal teams, and quality personnel to ensure product requirements are met. The Quality Engineer also supports the development of inspection processes, data collection systems, and metrology techniques for new and existing products.

Responsibilities

• Guide Quality Lab Inspectors and Technicians in evaluating dimensional, visual, and other design-defined features.

• Interface with customers for concerns, process changes, and requirements.

• Train production and quality personnel on the use of inspection equipment.

• Develop and perform inspection activities per customer and internal specifications.

• Set up and monitor data collection systems.

• Collaborate with Engineering and Production on new products and product lines.

• Perform part/assembly qualification activities.

• Develop metrology techniques and fixtures for accurate part measurements.

• Conduct performance characterizations such as force, gap, continuity, and hi-pot testing.

• Perform other duties as determined by the Director and VP of Quality.

Requirements

• Bachelor’s degree in engineering with 3–5 years of quality experience, associate degree with 5+ years, or minimum of 10 years quality experience.

• In-depth knowledge of manufacturing processes including injection molding, metal stamping, and assembly.

• Strong interpersonal, quality inspection, and customer communication skills.

• Proficiency in reading prints and advanced GD&T.

• Strong Microsoft Office skills (Excel, Word, PowerPoint).

• SPC and data analysis skills using Minitab software.

Biomerics offers the following benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, and 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 of 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. If Biomerics subsequently hires the candidate, Biomerics shall not owe any fee to the submitting agency.

Biomerics

About Biomerics

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

Industry
Manufacturing & Production
Company Size
1,001-5,000 employees
Headquarters
Salt Lake City, Utah
Year Founded
1994
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