Skip to Main Content

Supplier Quality Engineer

Aktiv Pharma Group
Broomfield, CO
  • Expired: December 15, 2022. Applications are no longer accepted.

Aktiv Pharma Group is a fast-growing company focused on addressing unmet medical needs through a proprietary drug delivery system. We are currently hiring for a Supplier Quality Engineer.

The Supplier Quality Engineer (SQE) is involved in the development, qualification, and maintenance of suppliers, systems, and practices which meet FDA Medical Device/Combination Product regulatory standards concentrating on the application of NPD Manufacturing Integration and Design Controls for pre-commercial devices. Supports QA function for supplier approvals, audits, and on-site incoming inspection activities

At Aktiv Pharma Group, we value the diversity of perspectives and backgrounds our employees bring. We are committed to achieving a diverse workforce through application of our equal opportunity employment policy and by providing a work environment free of discrimination and harassment. We work according to our values of truth, caring, goodness and perseverance, and encourage individuals with the required skill-sets and these values to apply.

The compensation range for the Supplier Quality Engineer is $95,000 - $110,000 annually.

Aktiv Pharma Group offers a wealth of benefits to our employees and their families.

Employee Benefits Include:

  • Medical Insurance (Cigna):
    • HDHP - Aktiv contributes the full monthly premium for the employee and their dependents.
    • Two additional premium medical plan options - Aktiv contributes a portion of the monthly premium for the employee and their dependents.
  • Vision Insurance (Principal/ VSP Network)
    • Aktiv contributes the full monthly premium for the employee and their dependents.
  • Dental Insurance (Principal)
    • Low Plan - Aktiv contributes the full monthly premium for the employee and their dependents.
    • High Plan - Aktiv contributes a portion of the monthly premium for the employee and their dependents.
  • Legal & ID Shield
    • Aktiv contributes the full monthly premium for the employee and their dependents.
  • Spending Accounts (Rocky Mountain Reserve)
    • FSA
    • HSA
    • DFSA
    • LP FSA
  • Ancillary Benefits (Colonial Life)
    • Accident
    • Group Medical Bridge
    • Voluntary Life AD&D
    • Disability
  • 401k (Human Interest)
  • Unlimited Paid Time Off
  • Bi-Monthly Internet and Cell Phone stipend
  • Fully Paid Membership for the employee and their dependents to Lifetime Fitness
  • Fully stocked office kitchen - Health conscious and Vegan!
  • Remote Work Options

Essential Duties/Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Builds and supports the Supplier Quality Engineering function by providing intelligence, discipline, problem solving and collaborative skills that can improve supplier selection, development, qualification, and ongoing issue resolution.
  • Primary point of contact for supplier development and component qualification activities including tool qualification, IQ, OQ, and PQ.
  • Establishes and implements supplier component management process for injection molded, machined, and laminated components throughout early product development, qualification, and commercial manufacturing.
  • Establishment and support of inspection methodologies including optical and tactile measurements.
  • Investigates non-conforming events and product failures as they relate to suppliers including root cause analysis and control implementation. Ongoing support and management of SCARs.
  • Supports technical issues in incoming inspection including non-conformances and continuous improvements.
  • Supports design, development, and early manufacturing portion of the Quality Management System (QMS) that can encompass Standard Operating Procedures (SOPs) that are required by the Federal Drug Administration (FDA) for medical device/combination products. Reviews/ approves SOPs in the QMS, EHS, and other technical areas as the Supplier Quality representative.
  • Provide support for supplier risk management activities including PFMEA development and statistical analysis and controls from a risk-based approach.
  • Other duties as required and necessary to ensure the success of the organization.

Job Qualifications

Competencies, Knowledge, Skills, and Abilities:
  • Ability to consistently promote, support, work, and act in a manner in support of Aktiv's mission, vision and values.
  • Proficiency in supplier component development, qualification, and commercial management for medical device and/or pharmaceutical products.
  • Familiarity with inspection methodologies including measurement
  • Strong ability for application and leading problem-solving and root cause analysis.
  • Must be able to interface well with others, especially Manufacturing Engineering, Research and Development (R&D) Engineering, Operations, and Project Management.
  • Experienced with statistical techniques, preferred familiarity with six sigma methodologies; able to analyze results.
  • Ability to work independently, with excellent organizational, communication, leadership and problem-solving abilities.
  • Knowledge of methods and process of medical device and/or pharmaceutical supplier qualification and development.
  • Knowledge of manufacturing equipment, drawings, ISO (ISO: 13485) regulations, Gage R&R, and advanced engineering concepts.
  • Familiarity with Risk Management per ISO 14971.
  • Well-versed in communicating effectively with knowledge of basic computer applications.
  • Experience with supplier selection, qualification, and issue resolution within pharmaceutical and/or medical device product development (combination product preferred but not required)
  • Understanding of Medical Device QSR and ISO 13485.

Experience:
  • Minimum five (5) years experience in supplier engineering in medical device or combination product environment is required. Minimum three (3) years experience in supplier selection and qualification activities in a new product development environment.
  • An equivalent combination of education and experience may be substituted on a year-to-year basis.

Additional Requirements/Licenses/Certifications:
  • ASQ (American Society for Quality) certified or Certified Quality Engineer or equivalent is preferred.
  • Must have reliable transportation.

Aktiv Pharma Group

Address

Broomfield, CO
80023 USA

Industry

Manufacturing