Quality and Compliance Manager

**Quality and Compliance Manager**

**Do you want to be part of something bigger where you have a clear career path?**

**What's in it for me?**

We offer an excellent benefits package including medical plan (blue cross blue shield). Retirement plan which includes a 401(k) plan with company match. Ten annual company paid holidays and fifteen paid vacation days, with vacation allowance increasing withtime served and an additional wellbeing day on top of this We also offer all employees up to three days volunteering to support local charities.

Do you want to develop? - We offer training, support to help you grow. You gain access to career progression opportunities globally within the Watson Marlow Business and our parent company Spirax Sarco

**Role Summary**:
This Devens Site Quality Manager opportunity offers an enriched and broad scope that involves working collaboratively with teams in supply chain, quality, engineering, and project management. You will provide strategic and day to day leadership to drivethe delivery of the WM, America Manufacturing Inc. business's Quality strategy and controls

You will be responsible for providing strategic and operational leadership to develop, implement and manage Quality Systems compliant with regulatory requirements. You will develop and lead cross-functional teams, lead the process on design controls, riskmanagement activities, complaint handling, CAPA, document control, supplier qualification and management, auditing.

**Key accountabilities include**:

- You will be a member of the senior leadership team (SLT) for the Americas regional Manufacturing site. In this role you will provide tactical and strategic leadership for site quality and compliance as well as being a key participant in the overall leadershipof the business
- Provide leadership, expertise and execute the setup of the QMS system for the site in compliance with latest applicable needs and regulations for all Americas locations. To start with this will be the implementation of ISO 9001:2015.
- Develop, implement, maintain, and continually improve the Quality Management System.
- Manage the QA department including document control, protocol writing, complaint handling, CAPA, supplier quality assurance program and all day-to-day quality department activities.
- Management representative responsible for leading management reviews, company-wide communications on quality system status and primary interface for external audits.
- Work closely with various functions within the company to create documents and systems.
- Ensure compliance with the quality system, as well as any applicable regulatory requirements
- Lead the QA function by developing, communicating, and building consensus for goals and programs that support company objectives
- Support group governance by active engagement and contribution to the group quality requirements and projects
- Maintain up-to-date knowledge of global medical device regulations and standards
- Provide ongoing support for sustainment of electronic systems, records, design of operational reports and dashboards and processes
- Use statistical analysis and quality techniques to collate, trend and analyse quality KPIs
- Provide advice and expertise to other America manufacturing locations as required.
- Assist line managers with future Watson-Marlow projects and other duties where necessary.

**This is what you'll need to be successful in this role**:

- Bachelor's degree in an applicable science or engineering discipline, or equivalent experience
- Strong hands-on experience with project management and collaboration on complex projects
- Robust experience managing people and teams to successful individual and professional outcomes
- Highly effective interpersonal, verbal, and written communication and organizational skills, with a self-motivated, achievement orientation
- Understanding of current quality-assurance risk-based techniques and their impact on internal procedures, product fit, form and function
- Experience with complex quality systems or medical device regulations which could include areas such as: ISO 13485, 21 CFR 820, AS9100, NADCAP or other
- Experience in managing a QA department including document control, complaint handling, CAPA, supplier quality assurance program and all day-to-day quality department activities.
- Demonstrated experience partnering, navigating conflict, and influencing teams cross functionally
- Ability to drive functional, technical, and operational excellence
- Strong analytical skills including Six Sigma Green or Black Belt certification preferred or equivalent skills and experience
- Certification by an accredited body in Quality Management or an associate discipline preferred

**Who are we?**

We are an industry-leading technology organization dedicated to engineering fluid management solutions for the life science and process industries. We help our customers to supply critical products and services that range from fresh drinking water and therapeuticmedicines to food products and paper. Through our solutions we help companies to be more efficient, sustainable, and profitable.