Quality Engineer - Design II

Description

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 Quality Engineer – Design II with a starting range of $94,000 - $114,000/year, dependent upon experience, education, and skills.  This position may have the opportunity for occasional work from home.

The Quality Engineer - Design II is a quality engineering position that has emphasis on developing and maintaining Paragon 28’s quality system and related quality activities specifically relating to product development, manufacturing, and supply chain of Paragon 28 products.

Key Responsibilities

• Participating on project teams as a contributing member by providing quality engineering support under the direction of Sr. Design Quality Engineers & management in the development of new products and processes, and continuously improving company’s products.
• Writing and reviewing procedures, plans, protocols and reports to ensure regulatory compliance.
• Develop acceptance criteria and measurement techniques for new product release.
• Perform Mechanical Inspections and use typical equipment used in inspection.
• Participate in Design Control and Transfer for release of new product development projects.
• Participate in and/or lead in the development and execution of verification & validation plans, testing, and generation of test reports.
• Author and assist in the development and execution of process validations with suppliers
• Perform statistical analysis for V&V testing requirements and develop MSAs and TMQs.
• Provide support for the manufacturing areas (internal and external). Work with production personnel and supervision to determine and monitor quality metrics, sample plans and address non-conforming product issues. Lead corrective and preventive action investigations to resolve the root cause of problems.
• Assist project teams on compliance with design control requirements per FDA QSR, European MDD/MDR, ISO 13485 and other applicable ISO/EN standards
• Participate in risk management activities in compliance with ISO 14971 as expressed in the company’s Quality Management System.
• Participate in supplier qualification process. Interface with suppliers to ensure product compliance to specification and perform supplier audits as needed.
• Accurately represents quality processes to 3rd party auditors (FDA, ISO 13485, MDSAP, etc.)
• Other duties as assigned

Travel

Less than 10% overnight travel. Supplier travel might be needed for on-site trouble shooting and or audits

Qualifications

• Bachelor’s degree in engineering or technical discipline and 3 years of related experience
• Familiarity with 21 CFR 820 and ISO 13485:2016 and other Government / ISO Standards
• Medical Device Design Controls
• Technical writing skills that include Quality Management Systems (QMS) and procedures
• Knowledge in Geometric Dimensioning and Tolerancing (GD&T)
• Verification and Validation experience
• Knowledge in Machining methodologies preferable (Titanium and Stainless-Steel experience best), knowledge of hardness, passivation, surface treatments, cleaning techniques etc. for communication with Suppliers and Engineers.
• Basic computer skills (MS Office)

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.

Salary : $94,000 - $114,000