Job Description

JOB SUMMARY:  Maintain the quality system and support supplier and incoming quality through the use of engineering tools and methodologies in order to support production, design, and development of medical devices.  

ESSENTIAL FUNCTIONS:  The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity.

• Work with suppliers and the Purchasing department to address quality issues with raw materials and components
• Maintain supplier approvals and certifications
• Review supplier quality agreements
• Make use of statistical techniques, risk analysis, Gage R&R, Cpk, ANOVA and DOE
• Solve problems using Cause & Effect diagrams, Failure Mode Effect Analysis, Root-Cause, 5-Why, 8D
• Maintain Quality Records
• Perform Corrective Actions and Non-conformance assessments
• Perform supplier audits as well as internal audits
• Support Incoming Inspection
• Review Work Instructions, Quality Plans, FMEAs, specifications, drawings, quality systems and analysis trends
• Participate in and lead continual improvement projects
• Travel up to 25% required for supplier support and audits

NON-ESSENTIAL FUNCTIONS:  

In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions.  Employees are required to follow any other job-related instructions and to perform any other job related duties requested by their supervisor.

QUALIFICATIONS:

• Bachelor’s Degree in Industrial, Mechanical or Biomedical engineering or equivalent experience.
• Very good written and verbal communication skills.
• At least 5 years of experience working with suppliers; preferably in the medical device or other regulated industry. 
• CQA or certified biomedical auditor certification helpful but not required.
• Experience with supplier audits and supplier management.
• Experience with quality management systems standards (ISO13845, ISO9001, AS9100)
• Accuracy, thoroughness, attention to detail, legibility in completing records is essential.
• Lean and 6Sigma knowledge a plus.

Notice to Recruitment Agencies and Headhunters

 Microline Surgical does not accept unsolicited resumes from agencies or third-party recruiters. Any unsolicited resumes or candidate information submitted to us, or to any of our employees, will be considered property of Microline Surgical without any obligation to pay referral or placement fees. To ensure our recruitment team has full visibility into open roles, we ask that all agencies and third-party recruiters adhere to our formal recruitment process and directly reach out to our HR department for any potential partnership.

REASONABLE ACCOMMODATION:

Microline is committed to the spirit and letter of the Americans with Disabilities Act and, as required by law, will reasonably accommodate otherwise qualified individuals.