QUALITY ASSURANCE SPECIALIST

Azienda

Italian based medical device startup

Descrizione

For an Italian based medical device startup, we are searching a

QUALITY ASSURANCE SPECIALIST

The QA Specialist will be responsible for maintaining and ensuring that the Company's Quality Management System.
In detail:

- Establish, manage and maintain compliance with ISO 13485, FDA QSR and European Union MDR, including establishment registration, new product submissions, CAPA system, etc.
- Accompany development projects, defining user requirements, design input and output, verification and validation methods, issuing development-accompanying and technical documentation for medical devices, revising already existing technical documentation.
- Create, manage and maintain risk management procedures aligned with ISO 14971, reviewing and updating product risk management files
- Support the planning and execution of internal and external audits
- Responsible for supporting the definition of Company's quality affairs goals each year
- Develop together with the management team yearly target budget and capital plans.
- Setup software and procedures to facilitate quality system compliance within the company
- Be the contact point for colleagues within the Company in terms of all questions concerning the technical documentation of medical devices
- Manage staff training on the topic of Quality Assurance

To apply, candidates must have:

- Minimum 5 years of experience in the biopharmaceutical, healthcare or life sciences industry, preferably in organizations with multiple clinical areas or with a focus on orthopaedic medical devices. 3 years of experience working in quality affairs departments. Working experience in an early-stage startup is a plus
- Strong working knowledge and application of the applicable quality standards and track record of successful regulatory audits and inspections
- Excellent understanding of and experience implementing Design Control and Risk Management in the context of new product development, from the ideation phase to the final regulatory approval, including post-market activities
- Minimum B.A/B.S. degree, preferably in an engineering or life sciences discipline. Any certification obtained on ISO 13485, ISO 14971, FDA QSR, EU MDR and other medical device relevant regulations are highly sought
- Demonstration of excellent communication, presentation, analytical, interpersonal and problem-solving skills through previous work experience. Ability to present/teach detailed technical information
- Proficiency with the following tools: Microsoft Office for Business, Google Suite Enterprise. Knowledge of existing e-QMS is a plus.
- English proficiency is a must

Luogo di lavoro:

Lombardia

Disponibilità:

Assunzione diretta

Tipologia:

Full Time

Data pubblicazione:

30/07/2020

Codice annuncio:

500267610

Visualizzazioni annuncio:

2130

Nome filiale:

LIFE SCIENCES

Numero di candidati ricercati:

1
NOTE LEGALI:
Experis è una compagnia eticamente responsabile. Il servizio è gratuito. I candidati ambosessi (L.903/77 - D.Lgs. n.198/2006) sono invitati a leggere l'informativa Privacy su www.experis.it Aut. Min. Prot. N. 1116 - SG - del 26/11/04.
Il titolare della registrazione e/o candidatura dichiara di essere a conoscenza delle sanzioni penali previste in caso di dichiarazioni mendaci o contenenti dati non più rispondenti a verità come previsto dal D.P.R. nº445 del 28.12.2000

QUALITY ASSURANCE SPECIALIST

Lombardia
Assunzione diretta
Full Time
30/07/2020
500267610
2130
LIFE SCIENCES
1

Azienda

Italian based medical device startup

Descrizione

For an Italian based medical device startup, we are searching a

QUALITY ASSURANCE SPECIALIST

The QA Specialist will be responsible for maintaining and ensuring that the Company's Quality Management System.
In detail:

- Establish, manage and maintain compliance with ISO 13485, FDA QSR and European Union MDR, including establishment registration, new product submissions, CAPA system, etc.
- Accompany development projects, defining user requirements, design input and output, verification and validation methods, issuing development-accompanying and technical documentation for medical devices, revising already existing technical documentation.
- Create, manage and maintain risk management procedures aligned with ISO 14971, reviewing and updating product risk management files
- Support the planning and execution of internal and external audits
- Responsible for supporting the definition of Company's quality affairs goals each year
- Develop together with the management team yearly target budget and capital plans.
- Setup software and procedures to facilitate quality system compliance within the company
- Be the contact point for colleagues within the Company in terms of all questions concerning the technical documentation of medical devices
- Manage staff training on the topic of Quality Assurance

To apply, candidates must have:

- Minimum 5 years of experience in the biopharmaceutical, healthcare or life sciences industry, preferably in organizations with multiple clinical areas or with a focus on orthopaedic medical devices. 3 years of experience working in quality affairs departments. Working experience in an early-stage startup is a plus
- Strong working knowledge and application of the applicable quality standards and track record of successful regulatory audits and inspections
- Excellent understanding of and experience implementing Design Control and Risk Management in the context of new product development, from the ideation phase to the final regulatory approval, including post-market activities
- Minimum B.A/B.S. degree, preferably in an engineering or life sciences discipline. Any certification obtained on ISO 13485, ISO 14971, FDA QSR, EU MDR and other medical device relevant regulations are highly sought
- Demonstration of excellent communication, presentation, analytical, interpersonal and problem-solving skills through previous work experience. Ability to present/teach detailed technical information
- Proficiency with the following tools: Microsoft Office for Business, Google Suite Enterprise. Knowledge of existing e-QMS is a plus.
- English proficiency is a must
NOTE LEGALI:
Experis è una compagnia eticamente responsabile. Il servizio è gratuito. I candidati ambosessi (L.903/77 - D.Lgs. n.198/2006) sono invitati a leggere l'informativa Privacy su www.experis.it Aut. Min. Prot. N. 1116 - SG - del 26/11/04.
Il titolare della registrazione e/o candidatura dichiara di essere a conoscenza delle sanzioni penali previste in caso di dichiarazioni mendaci o contenenti dati non più rispondenti a verità come previsto dal D.P.R. nº445 del 28.12.2000