Manager of Quality - Production

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 Manager of Quality - Production with a starting range of $121,000 - $145,000/year, dependent upon experience, education, and skills. This position requires a full-time onsite presence.

The Manager of Quality Production is responsible for ensuring the daily compliance of P28s quality management system within the quality team, including compliance to regulations and standards such as 21 CFR 820 and ISO 13485:2016. This position is also responsible for the management of people within this team.

Key Responsibilities

• Responsible for the implementation, training, management, maintenance, and growth appropriate for the expansion of the Paragon 28, Inc. (P28) quality system

• Responsible for supplier quality & P28 receiving inspection including guidance and oversight of all supplier verification and inspection plans

• Responsible for proper identification of NCRs and appropriate actions with assistance from other team members

• Assist the P28 Product Development and Purchasing departments to evaluate new suppliers for inclusion in the P28 Approved Supplier List

• Responsible for any Quality related Software Validations which affect the QMS or product quality

• Responsible for identification and execution of continuous improvement projects

• Manages Quality System management responsibility including all requirements as identified in 21 CFR 820 and ISO 13485; 2016

• Lead employees to meet the departmental and organizational expectations for productivity, quality, continuous improvement and goal accomplishment.

  1. Coach, mentor and develop staff, including recruitment and onboarding, performance management and career development.

• Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices

• Other duties as assigned

Travel

Less than 10% of overnight travel; potential for either domestic or international travel.

Qualifications

• Bachelors degree in Engineering or technical discipline and 5 years of related experience
• Demonstrated ability to lead and manage teams and direct reports
• Knowledge and experience with measuring equipment
• Read and understand part drawings/GD&T
• Expertise with 21 CFR 820/ISO13485, and other government/ISO standards
• Strong interpersonal and communication skills and the ability to apply these skills when dealing with all levels of the organization
• Solid computer aptitude, including proficiency with Microsoft Office suite
• Superior organizational skills, attention to detail and ability to prioritize and manage multiple tasks and competing deadlines.
• Knowledge of Ti and SS machining is a plus.

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 : $121,000 - $145,000