Quality and Compliance Manager

 

Primary Job Function

Responsible for product quality engineering activities providing high level of hands-on support throughout the product life cycle, from conception to commercialization and post-market evaluation in a cross-functional environment. Responsible for all aspects related to the quality of Company products, as well as Quality System processes, to establish and maintain compliance to all applicable regulatory requirements. The right candidate has quality engineering experience with electro-mechanical and software-based products and the ability to take on technical challenges through resolution.

Essential Duties and Responsibilities

  • Develops, maintains, improves, and audits a Quality Management System (QMS) that is functionally-compliant to ISO 9001:2015
  • Leads Design Quality and Compliance activities for new product development, working with PD Engineers to ensure compliance to ISO 9001:2015 and select medical device standards
    • Ensures products are developed to meet customer expectations and regulatory requirements
    • Applies knowledge of Design Control and Risk Management activities throughout the product lifecycle
  • Leads Manufacturing Quality and Compliance activities for production of new and existing products
    • Manages quality and compliance of Supply Chain, including qualifying all contract manufacturing and component suppliers, conducting supplier quality audits, and establishing Receiving and Outgoing Inspection methods, tests, and tools
    • Manages product non-conformances via SCAR process, complaint handling and post-market data collection and analysis, including root cause determination and coordination of associated CAPA activities
    • Manages quality and compliance of in-house Production and Servicing (as applicable)
  • Develops, implements, and maintains the Document Change Control system
  • Serves as Quality lead for business system implementations and other special projects
  • Roles and responsibilities may be shifted to maximize customer and Company success

Minimum Qualifications                                                                             

  • Bachelor’s Degree in an applied science or engineering field
  • 7+ years of Design and Manufacturing Quality Engineering experience with electro-mechanical and software products
  • Experience establishing or maintaining a QMS compliant to ISO 9001:2015
  • Demonstrated competency utilizing 9001:2015, 21 CFR part 820, 14971, 60601, APQP, and PPAP on past projects
  • Understanding of HIPAA and cybersecurity-related standards and guidance documents
  • Proven track record of success working with a globally-distributed manufacturing supply chain
  • Ability to work in a fast-paced early-stage startup where “many hats” must be worn
  • Exceptional analytical, problem-solving, and interpersonal communication skills
  • Understands and can subsequently explain complex quality details to non-experts
  • Exceptional organizational skills and attention to detail
  • Knowledge and experience with ERP/MRP systems and their applications
  • Administrative and financial management skills relative to job expectations
  • Willing and able to travel when required, up to 40%, domestic and international

 

To apply, send resume/CV to careers@activeprotective.com

 

About ActiveProtective

We are a growing venture-backed startup based in the Philadelphia region developing new-to-the-world personal safety products.  Our key focus is a wearable airbag for hip protection in the event of a fall, which represents a leading cause of disability and death in the elderly population.  We’re looking for passionate individuals to join our mission to make hip fractures a preventable condition.  For more information, visit www.activeprotective.com.

 

 

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