Operational Quality 1

Smith & Nephew; Hull and East Yorkshire; On-site; GBP 30,000 - 48,000; Full time

Benefits offered by this job

Generous annual bonus

Pension scheme

Private health and dental plans

Job summary

Smith+Nephew is seeking an experienced Quality specialist to join our Life Unlimited manufacturing quality team at Hull. You will partner with operations to ensure frontline quality, lead documentation review and support release of products.

Responsibilities include handling non-conformances, CAPA management, change control, audits, and ensuring compliance with ISO 9001/13485. Onsite role with opportunities to impact patient care and product quality.

Qualifications

• Degree in a quality-related field or equivalent experience.
• Strong analytical and communication skills are essential.
• Onsite role within the Hull site with ISO quality focus.

Responsibilities

• Lead frontline quality support for the operations value stream.
• Review and release intermediate and finished product documentation.
• Investigate non-conforming materials and manage CAPAs and NCs.
• Support Change Control and ensure QMS procedures are followed.
• Coordinate and participate in internal and external audits.

Skills

Quality Assurance

Root cause analysis

Documentation review

ISO 9001

ISO 13485

Education

Degree in relevant field

Tools

QMS software

Job description

Life Unlimited. At Smith+Neb? 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.

Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer.

Smith+Neb? We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it's our people who make Smith+Neb? a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it's our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We're a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.