Quality Engineer

Phagenesis Limited; Manchester; On-site; GBP 35,000 - 50,000; Full time

Job summary

An innovative medical device company is seeking a Quality Engineer to join their QARA department in Manchester. The role involves overseeing quality assurance activities, conducting product inspections, and ensuring compliance with regulatory standards. The ideal candidate will have a degree or quality qualification, alongside at least 4 years of quality experience in a medical device context. The company values collaboration and offers opportunities for professional growth in a dynamic work environment.

Benefits

Competitive salary range

Benefits package

Opportunities for professional growth and development

Collaborative and innovative work environment

Qualifications

• At least 4 years experience as a quality professional in a medical device company.
• Familiarity with ISO13485 and 21 CFR Part 820 processes & procedures.
• Quality Assurance and preferably Quality Control experience in a medical device company.

Responsibilities

• Lead root cause investigations and implement corrective actions.
• Inspect incoming and final product.
• Contribute to the continuous improvement of the QMS.

Skills

Attention to detail

Collaboration

Analytical skills

Problem solving

Education

Degree or quality qualification

Job description

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The QARA department is critical to maintaining quality compliance and product safety at Phagenesis, and the Quality Engineer role is vital to the department’s success. The position reports to the Senior Quality Engineer and involves both Quality Assurance activities e.g., supplier management and development of the QMS system; and Quality Control activities e.g., product inspection and release. The position also involves working in or supporting of other areas of the business on an as needs basis.

Responsibilities:

• Lead root cause investigations and implement corrective actions for NCMR’s and CAPA’s.

• Lead investigation of complaints to determine the root cause and applicable corrective actions.

• Inspect incoming and final product.

• Review & approval of label specifications.

• Inspect and release of labels.

• Review & approval of Device History Records (DHR) and other production documentation

• Review & approval of equipment records, including calibration and preventive maintenance

• Execute product release.

• Contribute to continuous improvement of the QMS including the implementation of new and revised QMS processes/documentation.

• Prepare data and participate in QMS Management Reviews and QA Metrics meetings.

• Provide support in the preparation and hosting of internal and external audits.

• Manage the change control process.

• A familiarity with operating to ISO13485 and 21 CFR Part 820 compliant processes & procedures

• QA and preferably QC experience in a medical device company

• Degree qualified or quality qualification

• At least 4 years experience as a quality professional in a medical device company

• A track record in supplier evaluation and monitoring

• Experience of product inspection and release

• Familiarity with management of complaints and non-conformances

• ISO13485 lead auditor trained

• Key competencies:

o High attention to detail

o Collaboration & teamwork

o Excellent verbal and written communication skills

o Good analytical, critical thinking and problem solving skills

o Ability to work independently and within cross-functional teams

What We Offer:

• Competitive salary range
• Benefits package
• Opportunities for professional growth and development
• Collaborative and innovative work environment

Phagenesis is an equal opportunity employer, committed to fostering a diverse and inclusive work environment. We welcome applications from all qualified individuals, regardless of ethnicity, sex, disability, religion/belief, sexual orientation, or age.

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We look forward to receiving your application!

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Device

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