Associate Quality Engineer - Rotational

Paragon 28's growth continues and we're looking for more great employees! Now is your chance to join this public company dedicated to improving a patient's quality of life with the treatment of the most challenging foot and ankle conditions! We are currently looking to fill the position of Associate Quality Engineer - Rotational with a starting range of $47,000 - $74,000/year, dependent upon experience, education, and skills. This position requires a full-time onsite presence.

The Rotational Associate Quality Engineer has varied responsibilities to assist both the Quality-Production and Quality-Design teams in ensuring Paragon 28's compliance to regulations and standards. The role will split time and/or rotate through day-to-day tasks and exposure to the supplier quality engineering, design quality engineering and production quality engineering roles at Paragon28 for a 12-month period, with the intention of aligning a candidate's skills and passion with business needs for permanent placement within the quality department

Key Responsibilities

• Participate on project teams as a contributing member by providing quality engineering support under the direction of SrDesign Quality Engineers & management in the development of new products and processes, supporting legacy released systems, and continuously improving company's products

• Assist in supplier qualification and dock-to-stock monitoring processes, including interfacing with suppliers to ensure product compliance to specification

• Support corrective and preventive action investigations to resolve the root cause of problems

• Provide technical support for the Quality Inspection Lab

• Implementation of lean process improvements under management direction

• Assist in managing, evaluating and dispositioning quarantined field inventory

• Assist in Out of Tolerance evaluations on measurement equipment

• Participate in equipment validations

• Participate in the non-conforming product process to address and resolve issues

• Perform Inspections and use typical equipment used in inspection

• Participate in risk management activities in compliance with ISO 14971 as expressed in the company's Quality Management System

• Other duties as assigned.

Travel

Less than 5% of overnight travel

Qualifications

• Bachelor's in engineering or technical discipline

• 0-2 years of related experience

• Medical device experience or other regulated industry preferred

• Knowledge and experience with measuring equipment preferred

• Experience reading and interpreting part drawings/GD&T and use of measuring equipment a plus

• Familiarity with 21 CFR 820/ISO13485 and other government/ISO standards preferred

• Ability and desire to learn quickly and work with minimal supervision

• Strong computer skills (MS Word & Excel)

• Strong technical writing skills

P28 is a leader in the development and distribution of medical solutions for the foot and ankle industry. Established in 2010,every member of our inspired and dedicated team serves a vital role in the achievement of our mission: to strategically build a company around the core principles that drive innovation and quality. We're located at 14445 Grasslands Dr., just off E-470 and Peoria St. on the east side of Englewood, CO.

We offer comprehensive medical coverage with generously subsidized premiums for both employees only and coverage with dependents. Plans include prescription drug and behavioral health coverage as well as telemedicine services. Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness), pet insurance and more. Free counseling services and resources are offered for emotional, physical, and financial wellbeing through our Employee Assistance Program. A safe harbor 401(k) Plan with 3% match and an Employee Stock Purchase Plan, which allows purchase of P28 stock at a discounted rate. You are able to accrue 19 days of PTO over 12 months to maintain a fulfilling work/life balance. Our working environment is considered Colorado Casual. Onsite we have a fresh food kiosk, free parking and will have a new, expanded fitness center!

Paragon 28 is an equal opportunity employer and values diversity. All employment decisions are decided on the basis of qualifications, merit and business need.

Notice to Recruiters and Staffing Agencies: to protect the interests of all parties, Paragon 28, Inc. will not accept unsolicited resumes or referrals from any source other than directly from a candidate or an approved vendor that has a written and signed agreement in place through the Paragon 28, Inc. HR department. Please do not contact or forward resumes or referrals to our company employees. Any unsolicited resumes will be considered Paragon 28, Inc. property. Paragon 28, Inc. is not responsible for any charges or fees related to unsolicited resumes or referrals.