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Quality Manager, US

$109k - $140k

Astro Studios

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 MedTech, 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. Role 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. 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) Qualifications 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 and developers deliver a fantastic service that meets the highest standards of Quality. This will involve broad duties to provide leadership in the US for internal QMS activities to ensure that we capture best practice and we remain compliant. We are looking for a natural leader to collaborate with the UK Quality Manager and engage with the management group in PA and with DES staff performing the work. Applicants are not expected to have gained experience across all the industry sectors noted but must have a thorough understanding of ISO 13485 and ISO 9001 quality systems. About You Competent Quality practitioner Proven experience in operational quality assurance within a regulated environment Strong working understanding of ISO13485, ISO9001 is a plus 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 If you are looking for a challenging role in QA covering a wide range of disciplines and diverse projects, where you will have internal and external-facing duties, and the chance to work across industry sectors, then this role might be what you are looking for. Additional information Life At PA encompasses our peoples' experience at PA. It's about how we enrich peoples’ working lives by giving them access to unique people and growth opportunities and purpose led meaningful work. Our purpose guides how we work with our clients and our teams, and support our communities, to deliver insight and impact, solving the world’s most complex challenges. We're focused on building a workplace that values human difference and diverse mindsets, and a culture of inclusion and equality that unlocks the potential in our people so everyone can be their best self. We are dedicated to supporting the physical, emotional, social and financial well-being of our people. Check out some of our extensive benefits: Group medical insurance Health Savings Account with company match Teladoc and informed nurse line resources Long term care plan Vision plan 401(k) Savings plan with company profit sharing contribution Commuter and Parking tax-savings benefit 15 days paid vacation with the opportunity to buy five additional days Company and Voluntary income protection benefits Gym and health incentive reimbursement Pet and legal insurance plans Employee Assistance Plan Annual performance-based bonus We’re committed to advancing equality. We recruit, retain, reward and develop our people based solely on their abilities and contributions and without reference to their age, background, disability, genetic information, parental or family status, religion or belief, race, ethnicity, nationality, sex, sexual orientation, gender identity (or expression), political belief, veteran status, or any other range of human difference brought about by identity and experience. We welcome applications from underrepresented groups. Adjustments or accommodations – If you need any adjustments or accommodations to the recruitment process, at either application or interview, please contact us at View email address on click.appcast.io In compliance with Colorado’s, New York & Massachusetts's Equal Pay Transparency Act, PA is required to provide a reasonable salary range for this role. This salary range is specific to the State of Massachusetts and is commensurate with experience, market data, applicant skills, internal equity and/or degrees/certifications. Salary Range: $ 109,000 - $140,000 #LI-JS1 #J-18808-Ljbffr

Vacancy posted 4 days ago
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