Quality Technician I

About the role

We partner and innovate with our customers to provide the highest quality, life enhancing medical devices in the world. This position will work to maintain elements of Quality Management Systems (QMS) in accordance with ISO13485 and FDA 21CFR820 requirements as well as company procedures and work instructions.

Responsibilities

• Manage daily workload under minimal supervision to meet personal/department goals.
• Maintain the focus needed to complete tasks in a timely, efficient, and detailed manner.
• Maintain a focus on details to complete tasks and documents accurately and with Good Documentation Practices (GDP)
• Perform visual and measurement inspections (in-process, incoming, final).
• Possess an understanding of gauging methods and blue-print reading.
• Perform Device History Record (DHR) reviews.
• Execute basic computer (ERP) transactions.
• Read and follow work instructions and procedures.
• Support completion of New Product Development initiatives
• Support completion of validation initiatives
• Support completion of calibration activities to ensure measurement accuracy.
• Communicate with co-workers respectfully and professionally.
• Perform other related duties as assigned.

Requirements

• Knowledge/Education: High School diploma or equivalent. Associates Degree in a technical field or other technical degree preferred.
• Experience: At least 2 years of experience in a manufacturing quality environment preferred.

Skills

• Possess an eagerness to learn and grow in the position and company (self-initiative).
• Basic understanding of blueprint reading, inspection equipment, and sampling plans.
• Basic understanding of blue-print reading in relation to the gauge used and part tolerance.

Physical Requirements

• Light physical activity performing non-strenuous day-to-day activities of an administrative nature.
• Minimal lifting (20 lbs.), carrying (10 lbs.), bending, pushing/pulling, crawling, climbing, balancing, and prolonged standing.
• Manual dexterity sufficient to reach and handle items.
• Requires the ability to identify and distinguish colors, visual blemishes and visual nonconformances (e.g., visualize objects of multiple dimensions).

Benefits

• Medical, dental, and vision benefits-effective on date of hire
• Generous paid time off benefits and 10 paid Holidays
• 136 Hours PTO (prorated based on hire date)