CQ Specialist - Tingley in Leeds

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

The Commercial Quality Specialist – Tingley supports quality activities for commercial and distribution operations within the UK market. This role ensures that sales, warehousing, distribution, and post‑market activities are conducted in compliance with applicable regulatory requirements, quality system standards, and internal procedures. The position plays an important role in safeguarding patient safety, maintaining regulatory compliance, and supporting reliable supply by partnering closely with Commercial, Regulatory Affairs, Supply Chain, and Operations teams.

Key Responsibilities

• Support commercial quality activities to ensure compliance with regulatory requirements, quality system standards, and internal policies.
• Support quality oversight of distribution and logistics activities at the Tingley site.
• Assist with post‑market surveillance activities, including complaint handling, investigations, and field action support.
• Partner with Commercial, Regulatory Affairs, Supply Chain, and Operations teams to support compliant product distribution and lifecycle activities.
• Support implementation and maintenance of QMS procedures, records, and controls applicable to commercial operations.
• Participate in internal audits, external audits, and health authority inspections.
• Monitor quality issues, trends, and metrics and support corrective and preventive actions.
• Maintain accurate quality documentation, records, and reports related to commercial quality activities.

Qualifications

Education: Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or a related discipline (required). Advanced degree in a scientific, quality, or regulatory field (preferred).

Experience and Skills:

Required: Typically 2-4 years of experience in Quality, Regulatory, or Compliance roles within a regulated industry. Foundational understanding of quality system requirements and regulatory expectations for commercial operations. Experience supporting post‑market surveillance activities, audits, or inspections. Ability to interpret quality procedures and regulatory requirements and apply them to daily activities.

Preferred: Experience in medical devices, healthcare, or other highly regulated industries. Familiarity with UK regulatory and quality requirements (e.g., MHRA expectations). Experience working in a multinational or matrixed organization. Exposure to health authority interactions or regulatory inspections. Quality or Regulatory certifications (e.g., ASQ, RAC). Strong attention to detail, documentation, and organizational skills. Effective communication and cross‑functional collaboration skills.

Other: Language: English. Travel: Limited; Occasional domestic travel within the UK. Certifications: Quality or Regulatory certifications preferred.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.