Quality Manager - AST

HOW YOU WILL MAKE A DIFFERENCE

About you:

Do you want to spend your working time making a difference in the world around you? Are you passionate about supporting the medical and pharmaceutical industries? Do you care about keeping patients and people safe? If so, then a career with Steris AST could be a great fit for you.

About Us:

At Steris AST we are the trusted experts in neutral sterilization offering includes radiation and gas technologies.

We offer electron beam, gamma, X-ray, ethylene oxide and vaporized hydrogen peroxide technologies for the purpose of product sterilization. Whether that product be a single use medical instrument, a hospital environment, cosmetics and toiletries, or food products, we make sure that everything that makes its way to an end user is safe for use or consumption.

We are currently recruiting for a Quality Manager vacancy. This is an excellent opportunity to join the business at a skilled professional level and help us maintain and build on the excellent quality standards we commit to.

WHAT IS INVOLVED

Lead the organization’s Quality staff to ensure compliance to the overall Quality Management System and drive continuous improvement.

Lead the organization’s Quality staff to ensure alignment to operations, support Lean efforts and drive quality improvement for services/processes.

Work closely with site senior management to provide strategic direction and development of the organization’s quality strategies and tactics.

Provide quality viewpoints and opinions on future service/technology offerings.

Provide coaching, mentoring and leadership to the Quality staff.

Serve as the site’s Management Representative and lead the organization’s Management Review process.

Ensure compliance with appropriate domestic regulatory and international standards and requirements.

Lead the organization's continuous improvement process; including data analysis, improvement projects and process capability to improve key metrics as measured by the product/service quality dashboard.

Lead and implement effective production and process controls.

Manage the CAPA, complaint and non-conformance handling processes to insure customer responsiveness and process improvements.

Responsible for successfully leading and managing Regulatory Agency and Notified Body inspections and driving the creation and implementation of sustainable and effective remediation plans.  Responsible for overseeing completion of Customer audits. 

Apply regulatory knowledge and judgment to the evaluation of quality concerns and regulatory compliance issues. 

Travel to other AST facilities, domestically and/or globally, to support remediation activities, audits/inspections and/or continuous improvement initiatives. 

Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards and regulations.

The position requires a level of authority to conduct and direct required activities such as quality planning, personnel management and regulatory compliance

REQUIRED EXPERIENCE

10 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.

10 years of experience with medical device or other regulated industries preferred.

10 years of experience working in an ISO certified environment required.

Minimum of 2 years in a Quality leadership role

Sterilization experience preferred

Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.

Skills

Excellent problem-solving skills

Focus on identification of potential issues and continuous improvement.

Experience working on cross-functional teams and on own initiative.

Effective interpersonal skills, ability to work independently under minimal guidelines and   supervision

Demonstrated excellent organizational, oral and written communications skills.

Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.

Ability to work in a fast-paced, regulated environment with strict deadlines and ever-changing  responsibilities

Mathematical skills including practical application of fractions, percentages, ratios, proportions and algebra.