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Senior Manager, Quality Systems

Work Location:

Minneapolis, MN, USA

Remote

FLSA Status:

Exempt

EEO Category:

Professional

Supervisor Role:

Yes

About the Role

Join us and become a member of an entrepreneurial team that supports the design and development of innovative new products for clients at Avio Medtech Consulting.

 

The main objective of the Senior Manager, Quality Systems is to successfully lead and execute the quality assurance and quality engineering function for the development of Avio’s portfolio of products and its consulting clients.

 

You are accountable and responsible for managing Avio’s Quality Management and either leading or supporting all quality-related activities, including QA aspects of product development, portfolio company quality and performance objectives, upkeep and conformance to all applicable quality standards, managing quality resource allocation (internal and third-party), and project budget.  You play an essential leadership role as part of the project teams working with the core team members to develop and execute project and business plans, and support efforts from product concept through commercial launch. 


Duties & Responsibilities:

  • Recruit, train, develop, and lead individual team members to accomplish personal and organizational goals, adhere to policies/procedures and reinforce a ‘culture of quality’

  • Oversee and manage the everyday quality assurance operational aspects of ongoing projects, including commercially released products

  • Responsible for all QA-related deliverables, including drafting and reviewing documents and managing review/approval processes

  • Establish quality assurance expectations that Avio and its portfolio companies can rely upon, aligning the organization to these expectations, and delivering on them

  • Influence and provide expert input in new product development programs and resources (internal and third-party) at all levels

  • Responsible for quality assurance aspects of high-performance teams, establishing each project's quality assurance metrics, and developing QA aspects of project and business plans

  • Directly responsible for oversight duties of third-party QA resources, including scope management, course correction, tracking execution, and communication

  • Effectively manages project outputs including user need requirements and product design requirements

  • Run or oversee routine internal audits

  • Run or oversee supplier controls

  • Support the management representative as required for management review and external audits

  • Maintain and improve quality management system procedures and processes

  • Maintain and improve QMS software, streamlining document control processes

  • Foster trust and transparency within the team in order to optimize team functioning and facilitate the discovery and appropriate resolution of QA issues

  • Evaluate QA project issues, develop resolutions, and ensure relevant issues are communicated to the Avio management team

  • Communicate QA plans, deliverables, schedules, budgets and manage review/approval processes

  • Conduct project QA review (QA lessons learned) in order to improve the effectiveness of the project team and the efficiency of product development with a focus on earlier identification of critical QA success factors and portfolio QA risk management 

  • Contribute to the implementation, maintenance and improvement of project management methodology 

  • Assess third party QA resource performance and effectiveness

  • Monitor QA aspects of projects from initiation through delivery

  • Develop mechanisms for monitoring QA improvement projects and mechanisms for intervention and problem solving with project team members, various third-party resources, various service providers, suppliers, and contract manufacturers

  • Other duties as assigned

Requirements

  • BS or BA in engineering or related field is required 

  • Minimum of 7 years of relevant quality experience

  • Minimum of 3 years demonstrated leadership experience managing direct reports

  • Demonstrated understanding of the scientific, technical, manufacturing, marketing and regulatory processes involved in the development of a medical device product. 

  • Experience in the medical device industry, covering supplier controls, corrective action preventative action, control of non-conforming material, product development

  • Familiarity with Microsoft Project or equivalent project management tools

  • Extensive understanding of Quality System Regulations (ISO 13485), FDA Regulation (21 CFR 820), and the Risk Management Process (ISO 14791)

  • Flexibility, persistence, passion, resourcefulness, a drive to succeed and an entrepreneurial spirit.

 

Nice to Haves:

  • ASQ Certification (CQE, CMQ, CRE etc.)

 

 

Physical Job Requirements:

The physical demands described within Position Description section within this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

 

Significant Work Activities:  Continuous sitting for prolonged periods, Keyboard use (greater or equal to 75% of the workday)

 

Travel:  Yes, <10% of the time

About the Company

Avio Medtech Consulting supports evolving medtech startups with proven expertise, streamlined processes, and trusted partnership to help simplify the complex from concept to commercialization to exit. Supporting entrepreneurs, their technologies, and their business is its focus. Avio supports as a strategic advisor, subject matter expert, project manager, and executor in a variety of functions throughout a venture’s journey. It brings the efficiencies of a cohesive, scrappy team backed by a robust and proven medtech playbook.

 

 

Avio Medtech Consulting is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

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