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QUALITY ENGINEER

The Quality Engineer works as an integral part of the SAM Medical Quality Assurance team responsible for release of high-quality medical products and continued maintenance of a compliant Quality Management System. The QE is the voice of Quality in the new product development process. The QE will serve as a resource to manufacturing to improve product quality, reliability, and process capability. The QE will be leading the identification, documentation, assessment, and correction of post-market product quality issues using risk management and root cause analysis tools. 

Reports to:
Quality Manager 

Key Duties and Responsibilities:

• Provide Quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development.
• Compile and analyze quality data using standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities; investigates relevant variables potentially affecting product and processes. Develop recommendations based upon the analysis.
• Establish and support a work environment of continuous improvement that supports SAM Medical’s Quality Policy, Quality System, and the relevant regulations for the areas they support.
• Presents Quality data to Management at periodic reviews of the Quality System.
• Work with R&D and Quality Assurance to create Quality Inspection Plans for components and final product acceptance for new products and existing product lines.
• Supports the First Article inspection program by developing process capability studies and validation plans to ensure expected quality levels for manufactured components are delivered.
• Evaluate, analyze and investigate customer/internal complaints then drive to resolve identified issues.
• Perform CAPA and SCAR investigations in a timely manner for product and process issues to ensure ongoing compliance with SAM Medical specifications and regulatory requirements.
• Collaborate with R&D and Manufacturing to identify, analyze, troubleshoot, and resolve out of specification product or process non-conformance issues.
• Participate in Material Review Boards, identify non-conformance trends and develop technical investigation plans.
• Develop, qualify/certify, and maintain supplier quality development and perform supplier audits. Primary Quality representative for supplier management and resolution of supplier nonconformances.
• Resolve any quality, test, and certification requirements in cooperation with R&D and Materials to assure overall agreement between SAM Medical drawings/ specifications and supplier expectations.
• Collaborate with project teams to ensure understanding of and compliance with regulations, procedures, and requirements. Provide training, guidance and interpretation as needed.
• Promote compliance with company procedures and regulatory requirements for medical device manufacturing. 

Requirements / Knowledge: 

• Five or more years of quality engineering experience in an FDA or other regulated industry.
• BS degree in science, engineering, or manufacturing.
• Prior experience with finished medical devices is required.
• Demonstrated knowledge of quality concepts, statistical analysis and DMAIC.
• Knowledge of international standards used in medical device design and manufacturing
• Experience with developing and guiding process validations (IQ/OQ/PQ)
• Experience with developing and guiding Gage R&R studies
• Strong problem solving and analytical skills with demonstrated knowledge of the application of statistical methods (e.g., SPC, DOE, capability analysis, etc.)
• Ability to plan, establish and coordinate test and inspection procedures, conduct process capability studies, prepare quality control data and develop statistically valid experiments
• Working knowledge of FDA 21 CFR Part 820 and ISO 13485 are required.
• Knowledgeable about medical device sterilization – ideally Gamma Sterilization.
• Strong interpersonal skills are required.
• Excellent verbal and written communication skills are required
• Project Management experience is preferred
• Ability to work on multiple projects simultaneously
• Certification as a Lead Auditor for ISO 13485 is preferred
• ASQ Certified Quality Engineer preferred
• Green or Black Belt certification is a plus
• Candidate must be results oriented, quick learner, respond to the urgent needs of the Company 

Working Environment: 

• Works generally at a desk in a well-lit, air-conditioned cubicle/office, with low noise levels
• Ability to sit for hours at a time, viewing computer monitor
• Some walking and standing relative to interaction with other company personnel
• Periods of multiple tasks and rapid deadlines may occur 

Work Schedule: 
The position is exempt, full-time days during the hours of normal business operations, work hours may include weekends when necessary. 

Travel:

• Long-distance or air travel is typically less than 20% annually
• Will need to possess a valid passport for international travel 

Physical Requirements:
Routinely lift more than 15-20 pounds. Ability to spend extended periods sitting and using a computer

Benefits:
As a valued SAM Medical employee, you will be eligible for our excellent benefit package including:

• Medical, Dental, & Vision Insurance
• 401K
• FSA
• Paid Holidays
• Vacation and PTO 

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this work. This is not an exhaustive list of all duties and responsibilities associated with it. SAM Medical Products management reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

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