Position Summary:
The Quality Lab Manager position performs management duties in the testing department in support of the lab’s objectives to provide test services that meet customers’ requirements for quality, quantity, and timeliness. The position’s responsibilities pertain to managing the quality lab in support of compliance with the quality system and component/product test service activities.

Minimum Qualifications:

• BS or MS in technical, life sciences, or engineering discipline
• Knowledge and understanding of ISO 13485, ISO 17025, and FDA 21 CFR Part 820 cGMP standards
• Quality assessment/audit experience is desirable
• 3-5 years in Quality Engineering for medical devices preferred
• Experience in the area(s) of Quality Systems Regulations; ISO 13485, ISO 17025, FDA 21 CFR Part 820 cGMP
• Supervisory experience

Knowledge, Skills, Abilities:

• Ability to organize and coordinate work efficiently, set priorities, and motivate others
• Possess a high energy level, attention to detail, and sense of urgency
• Microsoft Office Suite skills
• Strong analytical and problem-solving skills
• Knowledge of ASTM and ISO standard testing and practices preferred
• Strong customer orientation with excellent written and verbal communication skills
• Hands-on and multi-tasking skills

Essential Duties and Responsibilities:

• Manage the personnel and testing activities within the quality lab
• Participate in the quoting process associated with the test services (e.g., component/product testing) provided by the quality lab
• Ensure the resources within the quality lab are able to meet the objectives associated with accepted testing (e.g., lab personnel, gauges, equipment, etc.)
• Selection and hiring of direct reports with skills and competence aligning with quality lab requirements and in accordance with company policies
• Review protocols to confirm that defined test methods and sampling plans are appropriate
• Review and approve test reports associated with component/product tested within the quality lab, confirming that protocol objectives have appropriately been met
• Ensure testing is completed per the approved protocols and scheduled timelines
• Work with the Equipment Coordinator to support calibration and preventative maintenance activities associated with gauges and equipment located within the quality lab
• Provide supervision, performance reviews, and mentoring for all direct reports
• Oversee employee performance including disciplinary action (discipline in conjunction with HR)
• Review customer complaints and failure analysis associated with quality lab activities
• Represent the company during external audits for FDA, Notified Bodies, and customer audits
• Maintain site-specific quality metrics reporting system, ensure that quality metrics data are identified and monitored, and periodic trend reports are distributed to management personnel

For Your Benefits:

• Competitive salary
• Medical Insurance (BCBS): Eligible on the first day of employment
  • HSA-eligible health insurance
• Dental Insurance
• Company paid Vision, Life, and Long and Short-Term Disability insurance
• TeleDoc program
• Identity protection
• 401k safe harbor retirement plan
• 18 days of PTO
• Tuition reimbursement
• Paid time off for community outreach and volunteering

About Medical Murray:
Since 1996, Medical Murray has been a privately owned company producing finished medical devices, components, and subassemblies for customers around the world ranging from startups to the largest OEMs. We specialize in the development, testing, and manufacturing of permanent implants, delivery systems, and complex catheters for vascular, gastrointestinal, urologic, and other interventional markets. Our core goals are Integrity First, People Matter, First Class Service, Inspired Innovation, and Community Service. To learn more, please visit us at www.medicalmurray.com.

Medical Murray is an equal-opportunity employer.