Quality Engineer - Compliance

Cambridgeshire - UK

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Overview:

TekWissen is a global workforce management provider throughout the UK Europe and many other countries in the world. The below client is an American multinational pharmaceutical and biotechnology corporation.

Job Title: Quality Engineer - Compliance
Location: Cambridge UK (2-3 days on-site per week)
Duration: 12 Months ( 37hrs per week )

WorkType : Hybrid

Job Description:

The Quality Engineer - Compliance will be responsible for providing design control and risk management expertise to medical device and combination product development programs throughout the product lifecycle.
This includes the generation and review of design history and risk management file components as well as collaboration with cross-functional development teams.

Key Responsibilities:

Lead and manage design control and risk management activities for combination product development programs.
Ensure deliverables are compliant with clinical trials and commercial licensure requirements.
Facilitate risk management activities with external design companies and manufacturing facilities.
Ensure product development activities comply with internal and external quality and regulatory standards.
Provide input and support for design validation including human factors engineering assessments.
Support regulatory submission data generation for assigned device projects.
Assess external design companies and suppliers capabilities related to device development and supply.
Support device design and manufacturing investigations during clinical trials and commercial manufacture.
Assist in internal and external audits of the DCoE Quality Management System.

Educational & Experience Requirements:

Qualifications:

BSc MSc or PhD in a relevant science or engineering discipline (e.g. chemistry biology biomedical sciences mechanical engineering materials sciences chemical engineering).

Experience:

Minimum 5 years of relevant experience in the pharmaceutical combination product and/or device industries.
Experience in design controls and risk management for combination products.
Familiarity with ISO 13485 ISOCFR 820 21 CFR 4 and EU Medical Devices Regulation

Technical Skills:

Proficient in ISO 9001 ISO 13485 ISOCFR 820 21 CFR 4 and EU Medical Devices Regulation.
Knowledgeable in EN 62366 EN 60601 and EN 62304 standards.
Familiar with Human Factors Engineering and device assembly manufacturing processes.
Strong attention to technical details and accuracy.
Ability to work independently and prioritize multiple tasks.

Competencies:

Decisive: Agile learner with the ability to synthesize complex information.
Focused: Accountable for meeting the needs of customers and stakeholders.
Connected: Effective in building professional relationships with stakeholders.
Courageous: Consistent and trustworthy in actions and decisions.
Resilient: Adaptable to shifting priorities in response to organizational needs.

Physical Requirements:

Ability to sit for extended periods.
Willingness and ability to travel.
Possession of a valid driving license.

TekWissen Group is an equal opportunity employer supporting workforce diversity.

Overview: TekWissen is a global workforce management provider throughout the UK Europe and many other countries in the world. The below client is an American multinational pharmaceutical and biotechnology corporation. Job Title: Quality Engineer - Compliance Location: Cambridge UK (2-3 days ...