Essential Duties and Responsibilities Include: Monitor supplier performance and drive improvement and resolution of non-conformances directly with the supplier through the corrective action process. Increase number of source inspections and Dock-to-stock items. Establish and report on supplier Key Performance Indicators (KPIs). Manage the Approved Supplier List (ASL) and supplier audit schedule. Lead Supplier audit activities. Partner with R&D engineering to identify and qualify new suppliers. Identify and implement improvements to supplier selection/qualification and incoming inspection processes. Supervise the incoming inspection group. Support the quality management system as required. Perform other TransMedics task and duties as required.
REQUIREMENTS: BS in Engineering with at least 8 years of experience in a medical device manufacturing environment; minimum of 2 years in supplier quality. MS preferred. Lead auditor experience (Internal and/or Supplier auditing). Working knowledge and practical application of 21 CFR Part 820, ISO 13485, ISO 9001. Practical knowledge and experience using Minitab or other statistical analysis tools. Practical knowledge and understanding of various quality tools: Six Sigma DMAIC, FMEA, SPC, 8D Root Cause Analysis and Lean Manufacturing concepts. Understanding and application of Gage R&R and Measurement System Analysis. Thorough understanding of CAPA/SCAR and closed-loop corrective action system. Process validation experience including IQ/OQ/PQ. Ability to communicate ideas and information clearly, effectively and concisely.
Highly detail-oriented with strong organization and prioritization skills. Must possess a high level of energy with the ability to handle multiple projects and changing priorities. Must be results-driven and exhibit a sense of urgency. Experience with Geometric Dimensional and Tolerancing (GD&T) and the ability to read blueprints Basic metrology knowledge. Computer knowledge and experience with Microsoft Office. Six Sigma training/certification or Certified Quality Engineer/Auditor is a plus. Ability to travel is required (approximately 25%).
EDUCATION: BS in Engineering, MS preferred.
About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-###-#### or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position. Associated topics: biomechanics, biomedical, biomedical engineer, bioprocessing, medical, msat, neuro, neuroscience, nutrition, parenteral
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.