Supplier Quality Engineer II

at  Paragon 28 Inc

Paragon 28s growth continues and were looking for more great employees! Now is your chance to join this public company dedicated to improving a patients quality of life with the treatment of the most challenging foot and ankle conditions! We are currently looking to fill the position ofSupplier Quality Engineer II with a starting range of $81,500 - $102,000/year, dependent upon experience, education, and skills. This position may have the opportunity for occasional work from home.
The Supplier Quality Engineer II is a quality engineering position that has emphasis on developing and maintaining Paragon 28s supplier quality system and related quality activities specifically relating to product development, manufacturing, and supply chain of Paragon 28 products.

QUALIFICATIONS

• Bachelors degree in Engineering or technical discipline
• 4+ years in related field, preferably medical device or manufacturing.
• 1years in medical device industry or 3 years of supplier quality auditing experience in various industries.
• Familiarity with 21 CFR 820 and ISO 13485:2016 and other Government / ISO Standards
• Medical Device Supplier & Purchasing Controls
• Technical writing skills that include Quality Management Systems (QMS) and procedures
• Proficient in Geometric Dimensioning and Tolerancing (GD&T) preferable
• Process Validation experience
• Proficient in Machining methodologies (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

• Process Owner for Key Quality Processes: Supplier Management
• Lead supplier qualification process. Interface with suppliers to ensure product compliance to specification and perform supplier audits as needed.
• Participating on project teams as a contributing member by providing supplier quality engineering support in the development of new suppliers and processes, and continuously improving companys products and suppliers.
• Provide support for the manufacturing areas (external). Work with production personnel and supervision to determine and monitor quality metrics, samples plans and address non-conforming product issues. Lead corrective and preventive action investigations to resolve the root cause of problems.
• Auditing suppliers on time and per schedule
• Writing audit plans and audit reports for suppliers to all applicable standards and regulations
• Writing and reviewing of procedures, plans, protocols and reports to ensure regulatory compliance.
• Perform Mechanical Inspections and use typical equipment used in inspection.
• Assist with Design Transfer for release of new product development projects.
• Author and/or assist in the development and execution of process validations at suppliers
• Perform statistical analysis for testing requirements and develop MSAs, TMQs, and inspection correlations.
• Assist suppliers in completion of Supplier Corrective Actions per appropriate timelines
• Assisting project teams on compliance with purchasing requirements per FDA QSR, European MDD/MDR, ISO 13485 and other applicable ISO/EN standards
• Assist in risk management activities in compliance with ISO 14971 as expressed in the companys Quality Management System.
• Capture and calculate supplier metrics per scorecards on a regular basis
• Develop relationships with employees and suppliers to ensure team-oriented operation.
• Accurately represents quality processes to 3rd party auditors (FDA, ISO 13485, MDSAP, etc.)
• Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, identifying problems, generating alternatives, and recommending solutions
• Other duties as assigned