Quality & Compliance Engineer
Location: Cheltenham, UK (On-site)
Benefits: 27 days holiday plus Wellbeing day, Private Medical Insurance, Bonus scheme, Sharescheme, Enhanced pension plan, Life assurance, Discount scheme.
Role Overview:
The Quality & Compliance Engineer will support the Pharmaceutical Sector Hub by taking responsibility for the business unit’s (BU) quality assurance, quality control and compliance requirements to ensure the BU’s overall quality of the product portfolio is fit for market.
Your objectives and responsibilities will focus on…
* Ensuring processes to support the Quality Management System are developed, implemented and maintained while reporting on quality performance statistics.
* Conducting BU Quality Control activities such as product performance validation, weld cut sections and monitoring production controls.
* Maintaining BU compliance including FDA, EC1935, IS07 Clean Room validation, welder qualifications and product traceability.
* Managing the BU non-conformance process, upholding manufactured products to their respective design standard and investigating causes of non-conformity.
* Collaborating with the Warranty and Returns team to track and support Field Failure Records (FFR) submitted for BU products; owning and progressing Corrective and Preventative Actions (CAPA) and writing necessary quality reports.
* Maintaining BU data integrity, mitigating the risk of data loss, approving users and certification and identifying/implementing application improvements.
* Controlling quality documentation and taking responsibility for the generation, standardisation, formatting, updating and availability of BU certification.
Your previous experience is likely to include…
* A proven track record in Mechanical Engineering.
* Working within a Quality related discipline.
* Working knowledge of CNC machining and automated welding processes.
* Database management.
* Using conventional inspection equipment.
To be successful in this role you will…
* Demonstrate Company Core Values at all times.
* Maintain awareness and remain up-to-date with regulatory, statutory and voluntary requirements.
* Possess a relevant qualification.
* Possess knowledge of Lean Six Sigma.
* Demonstrate a strong understanding of the ISO9001 quality system.
* Take a structured approach and possess excellent attention to detail.
* Be able to read and interrogate engineering drawings, including geometric dimensioning and tolerancing.
* Be motivated to make a real difference to the business.
* Be commercially aware and possess excellent interpersonal and communication skills.
Benefits
You will receive a competitive salary (and a discretionary bonus), flexible working and excellent benefits including 27 days holiday allowance (before bank holidays), 3 days’ paid volunteering leave, comprehensive private healthcare, enhanced pension plan, life assurance, optional participation in a Share Ownership Plan, free onsite parking, flexible benefits, and access to a personal discounts’ portal.
Everyone is Included at Spirax Group
We are passionate about creating inclusive and equitable working cultures where everyone can be themselves and achieve their full potential. For us, that means supportive teams and strong relationships where everyone’s contribution is valued - across social and cultural backgrounds, ethnicities, ages, genders, gender identities, abilities, neurodiversity, sexual orientation, religious beliefs, and everything else that makes us human and unique.
We want everyone to be able to make their difference here, so we will always consider requests for flexible working.
We know that everyone needs some extra help from time to time too, so we have introduced a range of additional benefits through our Group Inclusion Commitments. These include gender-neutral parental leave, 15 days of extra paid caregiver leave, paid time off and support for anyone experiencing pregnancy loss or domestic abuse, menopause-friendly workplace principles and more.
We are also a Disability Confident Committed Employer. If you would like to apply using this scheme, please select this option in our application form or notify our recruitment partners.
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