Quality Systems Specialist

Biotech Healthcare; Roscommon; On-site; EUR 36,000 - 38,000; Full time

Job summary

Biotech Europe Meditech Inc. Limited is seeking a Quality Systems Specialist to reinforce the QMS, manage CAPA/NCR processes and ensure ISO13485 – 21 CFR 820 compliance across operations.

The role focuses on complaints handling, environmental monitoring, regulatory affairs support and change control, with cross-functional collaboration to uphold quality standards in a high-volume production environment. Strong data analysis and communication skills are expected as you drive continuous

Qualifications

• Previous work experience in a similar work environment is essential.
• Experience with ISO quality systems (ISO13485 – 21 CFR 820) is required.
• Strong change control and CAPA experience.

Responsibilities

• Manage recording, investigation and resolution of product complaints, problems, or safety issues.
• Run regular Complaint, CAPA, NCR and continuous improvement monitoring meetings.
• Generate KPI data around Complaint, CAPA, NCR and continuous improvement.
• Provide support to Quality Engineering and Operations for Risk Assessments.
• Ensure deviations to protocols are controlled and addressed by the Validation Project Team.
• Coordinate environmental monitoring activities and bioburden/microbial ID monitoring.
• Support Regulatory Affairs with international submissions and RA documentation.
• Assist with change notifications/Validation protocols and Reports.
• Provide ongoing manufacturing support for production transfers.
• Support quality role in new product introductions and transfers to production.
• Internal customer service: maintain data analytics resources for teams.

Skills

High Volume Production

Change control management

ISO13485 / 21 CFR 820

Independent opinion

Communication skills

Attention to detail

Problem solving

Risk Management (FMEA)

Education

School education level

University / technical college education level

Job description

Company: Biotech Europe Meditech Inc. Limited

Job Title: Quality Systems Specialist

SOC Code: 2462

Hours per Week: 40

Salary: 36000 - 38000 Euros Annually

ROLE:

Responsible for providing quality systems support for to all processes related to QMS. Assures that quality standards are maintained and assist with the implementation and compliance of the quality management program. Support company goals and objectives, policies and procedures, quality systems, and FDA regulations Employees are expected to support the quality concepts inherent in the business philosophies of Biotech Europe Meditech Inc Ltd, including a variety of job related tasks which may not be specific to this position profile.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

Quality Systems Complaints / CAPA / NCRs

• Manage the recording, investigation and resolution of product complaints, product problems, or safety issues. Coordinate and maintain the Corrective Action Program to assure appropriate investigation and implementation.
• Run regular Complaint, CAPA, NCR and continuous improvement monitoring meeting
• Generate KPI data around Complaint, CAPA, NCR and continuous improvement

Validation support

• Provide support to the Quality Engineering and Operations functions including Risk Assessment reviews and updates.
• Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team.

Environmental and testing

• Co-ordinate the environmental monitoring activities of the contractors
• Manage in process bioburden / Microbial ID monitoring
• Ensure all environmental metrics are maintained up to date

Regulatory Affairs Support

• Provide support to Biotech RA with all international country submissions
• Provide support to solve and reply to any regulatory query.
• Help to manage and maintain all RA documentation including Technical Master File

Operational Support

• Support the preparation of change notifications/Validation protocols and Reports.
• Support sterilisation validation / revalidisation
• Provide ongoing manufacture support to help the team meet its business objectives.
• Provide Quality role in new product introduction and transfers to production.
• Customer service - Internal: Develop harmonious working relationships with all functions, and ensure employees have the necessary information (data analysis) and resources to effectively perform their jobs.

EDUCATION:

• School education level
• University / technical college education level

EXPERIENCE:

• Previous work experience in a similar work environment is essential.

COMPETENCIES REQUIRED:

• Experience in working in High Volume Production Facility
• Strong computer skills - Change control management; design, process and system.
• Familiarity with ISO quality systems ( ISO13485 – 21 CFR 820) Good customer relation skills
• Ability to present an independent opinion
• Good communication and interpersonal skills -communicate highly technical information, both verbally and in writing, to both non-technical and technical associates.
• Quality of work / Attention to detail; maintains high standards despite pressing deadlines
• Problem Solving (using recognised tools) and decision making (makes sound factual decisions)
• Risk Management including FMEA generation