Job Description

About Aspen

We love what we do! At Aspen Surgical we live our values of Customer Focus, Integrity, Accountability, Collaboration, and Innovative Spirit every day. This caring dedication creates and builds exceptional products that drive the industry standard making a real and lasting impact on people’s lives around the world. We strive to be the best, while providing the tools, resources, and support needed to set our team members up for success.

PURPOSE OF THE ROLE:

Verify the conformance of purchased products to all product requirements, regulations and applicable standards through inspection to established criteria. This individual will also be responsible for the preparation of sterile loads for shipment to external sterilizers.

ESSENTIAL DUTIES AND RESPONSIBILITIES: - Other duties may be assigned

• Perform incoming inspection activities at Douglas facility.
• Prepare documentation and confirm load assembly of product for shipment to external sterilizers
• Perform First Article Inspections to qualify supplier's implementation of changed/new products.
• Support Quality Improvement initiatives to ensure products & processes comply with regulatory and Quality Management System requirements.
• Execute inspection plans for incoming purchased materials to ensure conformity to documented specifications.
• Verify receipt of Certificates of Conformity/Analysis as required and ensure such records are stored per procedures.
• Inspect product according to the requirements of a Skip-lot or Dock-to-stock inspection sampling plan to increase or decrease the level of inspections required based on risk, supplier performance and critical features.
• Maintain retained samples of finished products for key customers as required.
• Initiate non-conforming product dispositions for purchased materials.
• Support manufacturing and engineering to resolve technical issues.
• Execute quality release for shipments to final customers.
• Keep documentation complete, organized and properly identified.

EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS:

• Technical degree or high school diploma with minimum (1) year experience in a similar role.
• Minimum one year work experience in a regulated industry &uch as Medical device, biological, or similar field preferred.
• Strong written and spoken English skills
• Proficiency in Spanish preferred
• Ability to work independently and remotely
• Flexibility and Adaptability - make effective decisions and maintain effectiveness under changing circumstances and priorities
• Ability to read and analyze technical prints and drawings
• Problem Solving - able to perform root cause analysis and implement effective corrective actions
• Computer Skills - Computer skills including but not limited to Microsoft Office Suite and Minitab

QUALITY AND REGULATORY REQUIREMENTS:

• Knowledge of quality system including the quality manual, quality policy and applicable procedures and work instructions
• Establish, implement, and maintain the quality system in accordance to FDA Quality System Regulation and ISO 13485.

PHYSICAL REQUIREMENTS

• Ability to lift, lower, push or pull material up to and in excess of 50 lbs.
• Ability to stand for long periods of time and in front of a computer.

We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Diversity makes us better.