QA industrial compliance specialist

Experteer Italy; United States; Remote; USD 60,000 - 80,000; Full time

Job summary

A global leader in diagnostic solutions is seeking a Quality Assurance professional to ensure compliance with regulatory standards and manage documentation processes. This role involves supporting quality management systems and collaborating with diverse industrial teams to uphold high quality and safety standards in diagnostic healthcare solutions.

Benefits

Diverse and inclusive culture

Impactful work with patient care

Global collaboration opportunities

Qualifications

• 2+ years experience in quality assurance in medical devices or pharmaceutical.
• Knowledge of ISO 13485, ISO9001, FDA code, EU IVDR.
• Fluent in English.

Responsibilities

• Manage documentation to release manufactured lots.
• Support review and release of labeling documents.
• Verify application of the Quality Management System.

Skills

Strong verbal and written communication skills

Solid problem solving and analytical skills

Interpersonal skills

Ability to manage complex projects

Negotiation and influence skills

Education

Degree in scientific disciplines or biomedical engineering

Tools

Office pack (Excel, PowerPoint, Word)

Job description

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.
Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."
Why Join Diasorin?
* Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.
* Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.
Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.
Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.
Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!
Job Scope
Through the Quality Assurance function:
* to ensure that the industrial activities are fit for purpose, consistent and meet all internal and external requirements.
* to ensure the adequacy and updating of Quality System with respect to the regulatory and quality requirements.
* to ensure labeling, IFU and any related documentation (e.g. changes, SOPs, specifications, attachments, etc.) are in compliance with the regulatory requirements.
Key Duties and Responsibilities
* Manage the documentation to release the manufactured lots.
* Support the correct process of review and release of labeling documents, including Instruction for Use.
* Verify the application of the Quality Management System.
* Draft and review standard operative procedures.
* Support the correct process of review and release of quality system documentation.
* Escalate to the line manager risks associated to his/her activities that could impact the QMS.
* Verify that procedures are properly established and applied to prevent non-conformity.
* Support industrial departments in the process of requesting and applying the relevant Change.
* Evaluate the impact of the proposed Changes on its own field of competence.
* Collaborate during audits conducted by external bodies.
Education, Experience, and Qualifications
* Degree in scientific disciplines or degree in biomedical engineering.
* At least two years' experience in similar or equivalent positions in chemical/pharmaceutical or medical device companies, or experience in the production/quality control of medical devices.
* Knowledge of ISO 13485, ISO9001, FDA code, EU IVD regulation 2017/746 (IVDR).
* Use of Office pack (Excel, PowerPoint, Word).
* Risk management and related tools.
* Strong verbal and written communication skills.
* Solid problem solving and analytical skills.
* Solid interpersonal skills, including ability to negotiate and influence without authority.
* Ability to work in a team and promote teamwork, with respect for others.
* Strong communication and interpersonal skills with ability to work well in a high-pressure environment.
* Ability to manage complex projects and multiple projects simultaneously.
* Ability to achieve assigned results while respecting quality, compliance and efficiency, respecting times, deadlines and priorities.
* Strong competency in Customer Focus and Driving for Results.
* Fluent knowledge of the English language.
Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.
Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at [e-mail] or 1-800-328-1482 to request an accommodation.
The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.
Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.
Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.
This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.