Biomedical Innovations design, development, and manufacturing services are provided to major global medical device companies to support product realization, additionally our proprietary brand of products are produced and distributed to healthcare providers. Through these business models, we aim to extend our capabilities such as product development and design, in order to enhance the value provided to our customers.

Considering a job at Biomedical Innovations?

At Biomedical Innovations, we’re dedicated to working as a team, and encouraging each other to excel every day. As we continue to look for innovative ways to exceed the highest industry standards, we understand how important it is to recruit the right candidates. By aligning with talented individuals who help us deliver quality solutions and ensure consistency in our products and services. Here, you’ll work within a giant melting pot of smart, motivated people who are rewarded for their commitment to doing challenging work that pushes them to learn and grow. Here, your opportunities are endless.


Innovation

Our Leadership Team continues to invest in our associates - Our forward looking culture is like no other.

Health & Wellness

With a focus on healthy mind and body,  we strive to expand health and wellness incentives across our global operations.

Global Force

We bring together leading cultures and innovators - Join our dynamic and a culturally rich work environment.

Changing the World

Biomedical Innovations products change the pace of patient care with innovative wireless monitoring.


Advancement Opportunities

We believe in promoting and growing talent from within! Employees are offered opportunities to apply for open positions.

Compensation and Benefits

Specific benefits will vary by location. In general they include:

  • Competitive Financial Compensation
  • Training and Development
  • Healthcare Coverage
  • Health and Wellness Incentives
  • Disability Protection
  • Tuition Reimbursement
  • Retirement Plans
  • Service Awards

Diversity EEO Statement

Graphic Controls is an Equal Opportunity Employer. Graphic Controls considers applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation, or an other legally protected status.

Culture

Employees are offered great benefits and opportunities which make coming to work everyday something to look forward to. Employee satisfaction is proven by the simple fact that our average length of service is over 15 years.


Openings >> Quality Engineer
Quality Engineer
Summary
Title:Quality Engineer
ID:1806
Department:Quality
Location:Buffalo, NY
Description
We are looking for a Quality Engineer at Nissha Medical Technologies for our facility in Buffalo, NY! In this role, you will be responsible to assure that manufacturing processes comply with the product specification, customer requirements, and regulatory/government agencies requirements.  Control total quality and establish ways of evaluating the quality of products. Responsible to develop, modify, apply, and maintain, standards for quality operating methods, processes, systems, and procedures and ensure compliance of corporate and regulatory requirements including ISO 9000 and 13485 standards. 

Essential Job Functions include
  1. Ensure processes complies with the tolerances stated on the product specification and drawings QSR and ISO standards.
  2. Support product development activities i.e. DFMEA, PFMEA, PCP, PVP, TMV, and validation protocol reports IQ, OQ, PQ.
  3. Lead cross functional teams to improve process and product understanding.
  4. Act as main interface for all customer quality requirements for specific devices and responsible for meeting requirements.
  5. Assist in determination and implementation of test and inspection activities required for quality inspection. 
  6. Investigate and analyze manufacturing, customer, and supplier problems.
  7. Resolve customer quality issues by executing Corrective Action Preventive Action (CAPA) processes.
  8. Use Lean Six Sigma methodology and quality engineering tools to achieve continuous improvement.
  9. Implements process improvements including fixtures, tooling, production checks, testing/inspection devices.
  10. Establish mechanism to evaluate, measure, monitor and/or quality in our products to improve efficiency of the production process.
  11. Assist in trouble shooting in manufacturing, and engineering activities. 
  12. Review and approve product design.
  13. Participate in internal/external audits to ensure the effective implementation of Quality Management System (QMS).
Requirements, Knowledge, Skills & Abilities 
  • B.S. Degree in Mechanical Engineering or other Science related field
  • Minimum 5 years’ experience in QE capacity engineering in a manufacturing environment; preferably in a medical or pharmaceutical environment
  • CQE preferred
  • Working experience with the application of statistical methods in quality assurance systems and processes
  • Six Sigma Green Belt Certification preferred
  • Strong written and oral communication skills
  • Excellent organizational and interpersonal skills
  • Ability to work effectively in a team environment
  • Knowledge of 21 CRF 820 and cGMP’s
  • Ability to develop sound and simple systems to assure ISO and regulatory compliance
  • Provide recommendations based on business system results
  • Well-developed verbal, numerical reasoning and analysis sills with ability to draw sound conclusions
  • Ability to interact with operations management at all levels
  • Ability to take initiative; completion of tasks in an accurate and timely manner; attention to detail

 

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