Quality Specialist

TN United Kingdom; Bishop's Stortford; On-site; GBP 30,000 - 50,000; Full time

Job summary

An established industry player is seeking a Quality Specialist to join their Medisafe team. This role is pivotal in ensuring adherence to quality standards and regulatory compliance in a dynamic environment. The successful candidate will manage customer complaints, coordinate audits, and oversee calibration processes, contributing to impactful healthcare solutions. With a commitment to growth and learning, this position offers a unique opportunity to make a real difference in patient care and infection prevention. If you are driven by quality and compliance in a regulated industry, this could be the perfect role for you.

Qualifications

• 2+ years of experience in a regulated industry (FDA/ISO 13485).
• Strong background in customer complaint investigations and audit coordination.

Responsibilities

• Manage customer complaint investigations and documentation.
• Coordinate internal and external audits and support site inspections.
• Oversee calibration activities and ensure recordkeeping compliance.

Skills

Customer Complaint Investigations

Audit Coordination

CAPA and NCR Investigations

Calibration Processes

Supplier Quality Assessments

Job description

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

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 motivated by impactful work? Do you have a passion for Ultrasonic and sonic irrigators and consumables? If so, then a career with STERIS in our Medisafe team could be a great fit for you.

About Us:

At STERIS, we are a leading global provider of products and services that support patient care with an emphasis on infection prevention. Our mission is to help our customers create a healthier and safer world. Working at STERIS, you GROW, LEARN, and MAKE A DIFFERENCE.

We are currently recruiting for a Quality Specialist vacancy. This is an excellent opportunity to join us in a division that drives the business forward through innovation.

The Quality Specialist is responsible for assisting in the administration of the quality functions at a site to ensure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other applicable regulatory standards. This role involves coordinating document control transactions, site record retention, calibration, and inspection activities.

Key Responsibilities include:

1. Manage customer complaint investigations and complete complaint documentation.
2. Facilitate CAPA and NCR investigations and coordinate investigation documentation.
3. Review DHRs and support batch record release.
4. Manage record retention practices within the site.
5. Oversee site calibration activities and recordkeeping.
6. Support site inspection activities and recordkeeping.
7. Coordinate internal and external audits.
8. Support supplier quality and customer assessment activities.
9. Track and analyze site quality data.
10. Support targeted Lean activities.
11. Perform other duties as assigned.

Required Experience:

• At least two (2) years of experience in a regulated industry (FDA/ISO 13485).
• Experience with customer complaint investigations.
• Experience in audit coordination.
• Experience with CAPA and NCR investigations.
• Knowledge of supplier quality and customer assessments.
• Experience with calibration processes.

Equal Opportunity Statement:

STERIS plc provides employment and advancement opportunities without regard to age, disability, gender reassignment, marriage or civil partnership, pregnancy and maternity, race, religion/belief, sex (gender), sexual orientation, or any other legally protected characteristic as defined by UK employment law. Employment decisions are based on merit, qualifications, skills, and abilities to ensure the best candidate is selected for each position.

We support creating a diverse and inclusive workplace and strive to be an Equal Opportunity Employer.

Note: If you are not a passport holder of the country for the vacancy, you might need a work permit. For more information, check our Blog.

Applicants should not provide bank or payment details during the application process. All applications should be submitted via the 'Apply now' button.

Created on 26/04/2025 by TN United Kingdom