Quality Manager, US

About the 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.

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
• Conduct 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
• 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

• Certified 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

Benefits

• Group medical insurance
• Health Savings Account with company match
• Teladoc and informed nurse line resources
• Long term care plan
• Group dental insurance
• 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
• 10 paid holiday days plus 10 paid sick days
• Company and Voluntary income protection benefits
• Gym and health incentive reimbursement
• Pet and legal insurance plans
• Employee Assistance Plan
• Annual performance-based bonus