Position summary: 

Supports product development programs (new and sustaining). Leads proactive design assurance activities facilitating the development and release of high quality products. Ensures standard and process compliance. Provides investigative support/leadership when significant product quality issues arise. Emphasis is placed on knowledge of standards, regulations, investigative/root cause processes, and procedures supporting compliance to industry, PH, and CT/ AMI product quality norms/requirements. Provides technical expertise in the area of design assurance to Engineering, Operations, Customer Service and Field Service personnel. May include coaching and training respective to investigative methods, risk mitigation techniques, and general product safety (inc. Six Sigma, FTA, FMEA, HALT, etc.).

Responsibilities:

· Leadership and expert advice on design control practices and relevant regulations.

· Maintain and develop all documents related to products approbations (such as TF, ER, DoC, PD) and other product and design documentation required for regulatory purposes.

· Lead and provide expert advice of products compliance matters (such as EN60601 series)

· Provide leadership and expert advice in risk management (ISO14971) throughout product lifecycle including support of vigilance handling, corrective and preventive action.

· Act as the independent reviewer for all kinds of Design activities (such as Design Reviews and DHF control per QSR 820 and ISO 13485).

· Quality representative in IR investigation teams and product safety defects investigation teams identified in Engineering or Supply Chain.

· Be the center of knowledge of product safety and product compliance.

· Train and educate engineers to Design Control and products compliance aspects

· Conduct and support internal and external audits as required.

· Support PH QMS initiatives – drive simplification and standardization.

· Work closely with Engineering and be familiar with of all design controls activities, systems and control measures used by Engineering.

 

Requirements:

· Bachelor of Science in Engineering, clinical field, life science or equivalent

· Advance degree in technical, legal or clinical field – an advantage.

· 2+ years of experience in medical device engineering, R&D, QA or regulations 

· Ability to work with global QA, RA organization. 

· Ability to communicate effectively.

· Vocational English in writing