Quality Manager

Overview

Tower Point, 6th Floor, 27-43 Wormwood Street, Boston, MA 02210, United States of America, Boston 02210, US

We believe in the power of ingenuity to build a positive human future. As strategies, technologies, and innovation collide, we create opportunity from complexity. Our teams of interdisciplinary experts combine innovative thinking and breakthrough technologies to progress further, faster. Our clients adapt and transform, and together we achieve enduring results. We are over 4,000 strategists, innovators, designers, consultants, digital experts, scientists, engineers, and technologists.

And we have deep expertise in consumer and manufacturing, defense and security, energy and utilities, financial services, government and public services, health and life sciences, and transport. Our teams operate globally from offices across the UK, Ireland, US, Nordics, and Netherlands.
PA. Bringing Ingenuity to Life. PA’s Design, Engineering and Science (DES) function helps our clients conceive, build and scale complex physical and digitally connected products. We combine the application of deep science, world-class engineering and human-centered design to address global shifts in markets; from early-stage innovation to regulated, real-world deployments.

The team is a globally integrated team of 400+ across the US, UK, and Ireland working at the intersect of innovation strategy, product development and applied R&D. We partner with organizations ranging from ambitious start-ups to established global leaders across Med Tech, Defense, Consumer, Industrial, Transport and Energy sectors. Our capabilities span software, electronics, mechanical engineering, design, research, and testing, enabling us to take ideas from concept to scalable reality.

We are recognized for tackling the hardest problems – where technical depth, commercial impact, and real-world delivery really matter.

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 ISO
9001 and ISO
13485, 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.

In collaboration with the UK Quality Manager,

• 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)

The ideal candidate will be enthused by innovation, competent in Quality systems, knowledgeable about regulations and be driven to use their knowledge of product development to ensure that our scientists, engineers, designers…