Operational Quality 1

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

Smith+Nephew is hiring Operational Quality 1 .

A member of the Quality control team, the job holder performs a vital role in maintaining the highest levels of quality & compliance.

The job holder is responsible for front line Quality support ensuring the manufacturing value stream apply high levels of quality. Responsible for first pass quality review of documentation and records and leads the investigation and disposition of discrepant materials.

What will you be doing?

• Acts as the operational quality partner to operations value stream structure.

• Support and deputise for the Value Stream Quality Engineer.

• Leads the timely review and release of intermediate and finished product documentation.

• Archiving of quality documentation as per site procedures.

• Generation of COA/COC as needed for manufactured product.

• Follow documented processes to ensure that product disposition and release of compliant product are performed within agreed lead-times.

• Acts as SME in audits for front line quality issues.

• Raw material incoming inspection / sampling

• Leads the containment, investigation and disposition of defective intermediate and finished products, including the management of NC’s and CAPA’s as needed.

• To assist in Change Control activities ensuring outputs are correctly translated into procedures and are communicated.

• Assessment of Quality issues, containment of the issue and determine level of escalation within the Quality management system.

• When required, provide cover to review and release final products (electronic release to market)

• To assist in Change Control activities ensuring outputs are correctly translated into procedures and are communicated.

• Coordinate and manage raw material concession and shelf-life expiry extension requests ensuring compliance with QMS and CAPA system

What will you need to be successful?

• Educated to degree level with a minimum of 2.2 Hons or at least 3 years’ experience working within a quality related role within Medical Device / Pharmaceutical Industry e.g. ISO 9001, ISO 13485

• Awareness / understanding of company products, processes, procedures and personnel/structure.

• Strong analytical and communication skills are essential together with the ability to manage workloads to ensure high standards are maintained.

• Root cause investigation and problem-solving skills essential.

You. Unlimited.
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
Inclusion and Belonging: Committed to welcoming, celebrating and thriving on inclusion and belonging. Learn more about our Employee Inclusion Groups on our website (www.smith-nephew.com)
Your Future: Generous annual bonus and pension schemes, Save As You Earn share options.
Work/Life Balance: Flexible vacation and time off, paid holidays and paid volunteering hours, so we can give back to our communities.
Your Wellbeing: Private health and dental plans, healthcare cash plans, income protection, life assurance and much more.
Flexibility: Hybrid working model (for most professional roles).
Training: Hands-on, team-customised, mentorship.
Extra Perks: Discounts on gyms and fitness clubs, salary sacrifice bicycle and car schemes and many other employee discounts.