Quality Manager, US

PA Consulting•Boston, MA

1d•$109,000 - $140,000•Onsite

About The Position

We are seeking a US Quality Manager to work in collaboration with our UK Quality Manager to maintain and develop our Quality Management System (QMS), provide leadership for Quality specifically in the US and support globally across the company as a whole. PA’s QMS is certified to both ISO9001 and ISO13485, under which we operate a wide range of projects and need to ensure that both our QMS and the development projects comply with best practice, regulations and standards.

Requirements

Competent Quality practitioner
Proven experience in operational quality assurance within a regulated environment
Strong working understanding of ISO13485, ISO9001 is a plus
Strong communication skills
Great leadership skills to help inspire staff and coach where needed
The ability to develop, learn and apply Quality principles, best practice, and applicable regulations across multiple disciplines and industry sectors
Thorough understanding of ISO 13485 and ISO 9001 quality systems

Nice To Haves

Enthused by innovation
Knowledgeable about regulations
Driven to use their knowledge of product development to ensure that our scientists, engineers, designers and developers deliver a fantastic service that meets the highest standards of Quality
Experience across all the industry sectors noted

Responsibilities

Act as the champion for Quality for PA in the US and globally, with a focus on Design, Engineering and Science
Front external audits from ISO certification bodies for the QMS and from clients undertaking supplier approval audits for work
Be a point of contact to maintain the QMS, provide leadership and engage and help empower staff to take ownership of best practice and codify it in the QMS
Support usage and deployment of the eQMS system to drive change in the business that supports staff and improves compliance
Drive positive change through the organization to improve working practices, and the QMS itself
Develop and deliver the internal audit plan with stakeholders and undertake audits to assess effectiveness of both work and QMS, managing the CAPA process
Develop quality metrics and assess performance against and report findings
Conduct management review meetings and author the summary reports to assess effectiveness of the business and help develop the strategy and long-term plans
Train staff on QMS processes and develop innovative ways to train and engage staff to improve fluency to meet PA’s Quality goals and improve the overall culture of Quality
Support client projects, specifically in regulated industries, ensuring activities meet relevant Quality standards / design controls for regulated development
Serve as a subject matter expert on Quality/design controls on projects
Oversee product release and CE marking/UL listing (for self-declaration) where applicable (e.g. for machinery)