Operational Quality 1

Smith Nephew; Hull and East Yorkshire; On-site; GBP 35,000 - 48,000; Full time

Benefits offered by this job

Generous annual bonus and pension

Save As You Earn share options

Flexible vacation and time off

Private health and dental plans

Gym discounts and cycle schemes

Job summary

Smith Nephew is hiring for an Operational Quality 1 who will partner with the operations value stream to maintain high quality standards across manufacturing. The role covers documentation review, release, and handling non-conforming materials.

You will lead containment, investigations, CAPAs, and support Change Control, with onsite work and a focus on timely product disposition.

Qualifications

• Degree level with 2:2 or 3 years’ quality experience in Medical Device/Pharma.
• Awareness/understanding of ISO 9001/13485.
• Strong analytical and communication skills.
• Root cause investigation and problem-solving skills.

Responsibilities

• Provide front-line quality support to the operations value stream.
• Lead timely review and release of intermediate and finished product documentation.
• Lead containment, investigation and disposition of non-conforming materials.
• Assist Change Control activities and translate outputs to procedures.
• Coordinate and manage raw material concessions and shelf-life extensions.

Skills

Quality assurance

Root cause analysis

Documentation control

Audit support

Communication skills

Education

Bachelor's degree in a relevant field

Tools

QMS software

CAPA system

Change Control

Job description

Life Unlimited.

At Smith+Nebhew we design and manufacture technology that takes the limits off living. Smith Nephew is hiring Operational Quality 1, who will play a vital role in maintaining the highest standards of quality and compliance.

The job holder will be responsible for providing front-line Quality support and ensuring that the manufacturing value stream applies high-quality standards. They will also be responsible for the first-pass quality review of documentation and records, and for leading the investigation and disposition of non-conforming materials.

What will you be doing?

• Acting as the operational quality partner to the operations value stream structure.
• Supporting and deputies for the Value Stream Quality Engineer.
• Leading the timely review and release of intermediate and finished product documentation.
• Archiving quality documentation in accordance with site procedures.
• Generating CoAs/CoCs as required for manufactured products.
• Following documented processes to ensure that product disposition and the release of compliant products are performed within agreed lead times.
• Acting as an SME during audits relating to front-line quality issues.
• Performing raw material incoming inspection and sampling.
• Leading the containment, investigation, and disposition of non-conforming intermediate and finished products, including the management of NCs and CAPAs as required.
• Assisting with Change Control activities, ensuring outputs are correctly translated into procedures and effectively communicated.
• Assessing quality issues, implements containment actions, and determines the appropriate level of escalation within the Quality Management System (QMS).
• Providing cover, when required, for the review and release of final products (electronic release to market).
• Coordinating and managing raw material concession and shelf-life extension requests, ensuring compliance with the 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 are essential.

Onsite role.

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.

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.

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