Quality Engineer

About The Company

Intech Medical is a global market leader and game-changer in the manufacturing of orthopedic medical devices. It all starts with innovation, and nobody knows this better than Intech. With manufacturing facilities around the world and unique initiatives and savoir-faire, Intech is at the forefront of technological innovation in the field of orthopedic device manufacturing as well as asset management, ensuring that optimal patient care is delivered day in, day out. This is who we are. We tech care.

Here at Lenkbar LLC dba Intech Medical we give our customers the competitive edge in today's highly specialized design and development of cutting tools. We assist with the design and production of a variety of drills, burrs and taps for the orthopedic industry and world class flexible shafts to meet our customers' most demanding requirements. From Swiss turning to precision grinding, we leverage advanced machining techniques and best-in-class equipment that are automated and optimized for performance to support our customers' next critical product launch.

Position Summary

Create inspection criteria using inspection methods that meet customer and BMI requirements. Perform a variety of quality and manufacturing support activities for efficient inspection of high-quality parts.

Essential Duties And Responsibilities

• Establish inspection criteria as part of the quality planning process for new and existing products using Solid Works Inspection and Excel.
• Act as liaison between QC and project engineers to ensure that inspection process capabilities have been verified and appropriately documented.
• Review drawings during quote review process to determine the feasibility of inspection measurability for all features.
• Ensure measurement methods defined on criteria is consistent with available gaging equipment and capabilities.
• Collaborate with a team of R&D, manufacturing engineer and programming personnel to ensure an accurate, effective and efficient up front planning process.
• Participate in the engineering change process as the quality representative by updating and creating new inspection criteria documentation based on the revision level changes.
• Support prototype activities of new products for quality and efficiencies, as well as, inspection and test activities.
• Participate in the product validation process as the quality representative by reviewing and approving verification and validation documents.
• Participate in the contract/order review process as the quality representative by verifying all quality engineering steps on the contract review form have been completed and sign off on the contract/order review form confirming all necessary steps and tasks are completed.
• Review and create documents needed during contract/order review process.
• Ensure the control of records by reviewing and approving documentation and records.
• Coordinate customer part and product approval process with internal departments and in conjunction with the customer.
• Complete non-conformance evaluation document for gages found out of calibration.
• Responsible for Gage R&R and PPAP processes.
• Evaluate ECNs and update all necessary quality and inspection documents.
• Investigate and evaluate issues during audits that may be considered CAPAs.
• Complete all documentation per ISO 13485 and FDA requirements.
• All other duties as assigned.
  
  

Knowledge, Skills & Competencies

• Minimum of5 years of quality control experience in a machine shop environment.
• Ability to manage multiple productions simultaneously without supervision.
• Experience is ISO 13485 /FDA 21CFR820 preferred.
• Experience with Solid Works preferred.
• Ability to read and interpret detailed blueprints and follow assembly instructions.
• Proficient in the use of machine shop precision measuring equipment including micrometer & caliper, height stands, thread gages, dial indicators, gage pins, radius gages, optical compactor and vision machines, and ability to determine the most efficient method of performing quality checks.
• Knowledge of the company quality system, as well as contractual quality requirements that vary by customer.
• Proficient in the use of a computer in a Windows environment, and proficient in Microsoft Excel.
• Proficient in GD&T and metrology. Gage R&R preferred.
• CMM & Vision equipment programming experience a plus.
• Proficient in math, including the ability to add, subtract, multiply and divide.
• Excellent manual dexterity, hand/eye coordination.
• Ability to be highly accurate with a high attention to detail.
• Ability to troubleshoot and problem solve quality and other issues.
• Ability to read and comprehend work instructions.
• Ability to repeat the same physical and mental activities over and over.
• Ability to maintain a sense of urgency, handle stressful situations, multitask and ability to prioritize work.
• Ability to work in a team environment as well as autonomously.
• Ability to communicate and interact effectively, professionally and constructively.
  
  

Qualification: Education, Certifications/Licenses and Experience Requirements:

• Education: Bachelor's degree required, preferably in an engineering discipline (e.g., biomedical, mechanical, or industrial).
  
  

Experience

• Experience in medical device or FDA-regulated industries, quality systems/assurance, or quality control is strongly preferred.
• Proficiency in technical writing and Microsoft Office applications (Word, Excel, PowerPoint) is required.
• Experience in computer programming (HTML, VBA), graphic design, or photo editing is a plus.
• 5 years' experience as engineer in manufacturing quality assurance, product quality assurance or manufacturing engineering
  
  

Skills

• Excellent verbal and written communication skills.
• Strong analytical and problem-solving abilities
• English proficiency required (bilingual to Spanish language is preferable)
  
  

Work Environment

• The noise level in the work environment is usually moderate.
• 98% of the time is spent in an office environment and 2% as needed on the shop floor or in the quality lab.
• Includes potential exposure to sounds and noise levels that can be distracting or uncomfortable.
• Includes potential exposure to moving mechanical parts.
• Includes potential exposure to coolants and oils.
• Work environment is temperature controlled.
  
  

The work environment described here is representative of that which an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Job Posted by ApplicantPro