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Director of Quality

Company: Paragon 28 Inc
Location: Englewood
Posted on: February 25, 2021

Job Description:

Grasslands Corporate Office - Englewood, CO Position Type Full Time Salary Range $170,000.00 - $195,000.00 Salary/year Travel Percentage 10% - 25% Travel Job Shift Day Description Paragon 28, Inc. is a leader in the development and distribution of medical solutions for the foot and ankle industry. We are experiencing tremendous growth and looking for enthusiastic people to join our team at our Corporate Office located at 14445 Grasslands Dr., just off E-470 and Peoria St. in Englewood, CO. Established in 2010, we are dedicated to creating industry leading solutions and tools to improve the treatment of the most challenging foot and ankle conditions. 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 offer 100% employer-paid medical, dental and vision benefits for employee only coverage and generously subsidized premiums for coverage with dependents in addition to company paid life and disability benefits. Voluntary life/disability/accident options as well as flexible spending account plans are also available. We have a safe harbor 401(k) Plan with 3% match and PTO Plan allowing accrual of 19 days 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 fitness center! This position has a starting range of $170,000 - $195,000/year, dependent upon experience, education and skills. Paragon 28 is an equal opportunity employer and values diversity. All employment decisions are decided on the basis of qualifications, merit and business need. Job Title Director of Quality-- Reports To Sr. Director of Quality & Regulatory Affairs Job Overview The Director of Quality has overall responsibility for all aspects of the quality system including compliance to regulations and standards such as 21 CFR 820 and ISO 13485:2016. This position also has overall responsibility for the management of all employees within the Quality organization. Essential Responsibilities and Duties

  • Overall responsibility for ensuring the implementation, training, management, maintenance and growth appropriate for the expansion of the Paragon 28, Inc. (P28) quality system
  • Responsible for the Quality requirements associated with new product development in design control including the management and implementation of P28 Design History Files and Technical Files
  • Responsible for ensuring proper programs/procedures are in place for supplier quality & P28 receiving inspection including guidance and oversight of all supplier verification and inspection plans
  • Responsible for ensuring new supplier evaluations are in place and followed by the P28 Product Development and Purchasing departments for inclusion in the P28 Approved Supplier List
  • Designated Management Representative for ISO and FDA audit
  • Overall 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.
  • 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
  • Reports to Sr. Management on quality issues and trends
  • Other duties as assigned This job operates in a distribution office environment. This role routinely uses standard office equipment such as computers, phones and copy machines. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to communicate with individuals internal and external to the organization. The employee is required to have close visual acuity to perform activities such as inspecting small parts and viewing computer terminal. The employee is frequently required to move about the facility. The employee may be required to lift up-to 15 lbs. by themselves. Position Type/Expected Hours of Work This is a full-time position with typical business hours for apposition of this level. It may reasonably require additional hours during the week and weekend; specific requirements will be determined with Manager. Travel Less than 20% of overnight travel; potential for either domestic or international travel. Qualifications
    • Bachelors degree in Engineering or technical discipline and 7 - 10 years of related experience
    • Demonstrated ability to lead and manage teams and direct reports (minimum 3 years management experience required)
    • Demonstrated experience as a Management Representative during onsite audits
    • Knowledge and experience with measuring equipment
    • Read and understand part drawings/GD&T
    • Expertise with 21 CFR 820/ISO13485, and other government/ISO standards
    • Basic computer skills (MS Word, Excel)
    • Knowledge of Ti and SS machining is a plus.

Keywords: Paragon 28 Inc, Denver , Director of Quality, Executive , Englewood, Colorado

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