This position is focused on product quality and supports Production, Incoming Inspection, Purchasing, Customers, Suppliers and Engineering. This function interprets, defines, and develops product quality requirements, as needed. It is also responsible for identifying, analyzing, troubleshooting, and resolving complaints and non-conformance issues. In addition, this position will drive continuous improvement activities in product quality as well as quality management system processes.

Position Qualifications

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance. These competencies are generally demonstrated through specific service, education, or training.

Knowledge: Acquired through education, certifications, training, experience.

• Understanding and experience in AQL inspection, control plans and interpretation of spec and drawings.
• Basic understanding of mechanical engineering concepts.
• Ability to analyze defective products.
• Strong decision-making abilities.
• Demonstrated technical writing skills.
• Proven ability to work across organizational functions.
• Strong ability to multi-task and to manage time.

Level of Experience:

• Three to five years of experience in Quality is highly preferred.
• Exposure to the FDA, medical device or medical manufacturing is a plus.
• Experience in continuous improvement is preferred.
• Experience in quality systems and management is a strong plus.

Level of Education:

• A Bachelor's degree in mechanical, biomedical, industrial or manufacturing engineering is preferred.
• ASQ certification is a plus.