IIMAK Quality Engineer in Amherst, New York

Title:Quality Engineer


Department:Planning/Manufacturing Operations


Founded in 2003, iiMED is an ISO13485 certified contract manufacturer of Class I and Class II medical device consumables.

Our experienced Program Management and Sales team at our corporate office in Buffalo, NY works very closely with our manufacturing facility located in Reynosa, Mexico. We have a broad range of capabilities that produce finished medical devices in the following segments: Compression Devices, Orthopedic Softgoods, Patient Mobility and Sterile Supplies.

We have enjoyed significant growth since our inception and are looking for highly motivated and talented people to help us continue our rapid growth while providing outstanding customer care. We currently have an opportunity at our Maquiladora located in Reynosa, MX and are seeking a strong candidate to join iiMED as a Quality Engineer.

Position Description: The responsibilities include assisting with the development of quality systems, procedures and controls to ensure that products consistently meet performance and quality specifications. The Quality Engineer is a leader and strong technical resource who will quickly, effectively and permanently resolve quality problems with internal and external customers and suppliers, helping to drive improved performance, efficiencies, as well as scrap and waste reduction. Additionally this position will provide a strong technical resource for product development, DOE, analytical and statistical needs, and lean initiatives.

Responsibilities Include:

• Support improvement of products, processes, and systems to reduce and eliminate inefficiency, waste and scrap to ensure iiMED maintains the highest quality of products, services and customer satisfaction.

• Problem solves and performs analysis through proper statistical methods.

• Supports testing and evaluation of manufacturing qualifications for new product development as well as product re-engineering for all product lines.

• Defines CTQ characteristics, specifications, and testing for new and existing products and processes.

• Identify opportunities, lead quality initiatives throughout our organization to drive iiMED towards six sigma quality levels including manufacturing product teams, customer service/support teams, field service improvement teams

• Support/lead implementation of quality tools, systems (ie. Six Sigma, ISO); establish testing practices and standards.

• Support/lead process improvement / Continuous Improvement (ie Kaizen, Lean) initiatives.

• Train others in support of our quality culture.

• All other duties as assigned.

In order to be considered for the position, candidates should possess:

(Qualified candidates must be able to perform the essential functions of the job)

• BS degree or equivalent in Engineering or related field is required

• Minimum 2 years of applicable process manufacturing experience required, 5 years preferred.

• Strong interpersonal and written communication skills and ability to interact with all levels of the organization.

• Strong working knowledge of Quality Systems and methods, Lean concepts, Six Sigma (DMAIC) methodology. Green or Black Belt is a plus.

• Strong practical and applied understanding of statistical analysis and tools including MSA, SPC and DOE.

• New and re-developed product launch experience a plus.

• Basic experience in ISO/FDA Controlled document management is also a plus.

• PC skills to include MS Office (Word, Excel, PowerPoint, Outlook) and Minitab.

• Excellent problem-solving and analytical skills.

• English/Spanish Bi-lingual a plus

iiMED is dedicated to providing employees with a business environment that supports communication, commitment and the opportunity for advancement. We are positioned to offer an attractive compensation and benefits package to match this exciting opportunity. If interested in joining a dynamic organization with global presence and applying for this career opportunity, please apply online at www.iimak.com/careers.

EOE M/F/Disabled/Veterans iiMED is an equal opportunity employer committed to workforce diversity.