北京招聘

Summary / Purpose:

This position is responsible for ensuring compliance with FDA/GMP/QSR and ISO 9001/13485/CMDR/CE/ SFDA and other applicable regulatory standards and requirements at assigned sites (SUD, single use medical devices and EMS, electronic manufacturing systems). Failure to identify and recommend corrective actions could result in legal enforcement action, critical delays in schedules and/or departmental operations and may jeopardize overall business activities.

Position is responsible for ensuring effective processes in the quality system (e.g. QMS SOPs, Documentation Control, Training, CAPA, etc.) are established and maintained at each assigned sites.

Essential Duties and Responsibilities:

?Ensure full compliance with Federal, State and local regulations.
?Ensure appropriate training for all personnel in-line with GMP/QSR, ISO9001/ISO13485/CMDR/CE and associated regulatory standards and requirements.
?Assists in global internal audit functions,
?Manages, develops, plans and implements programs for the following functional areas: QS Compliance, Document Center, Labeling, Configuration Management, Regulatory and Project Coordination and validation (Sterilization, Process & Equipment)
?Ensures effective interactions with quality teams at each assigned site to effectively incorporate site/company strategies and quality systems.
?Assists with company-wide training related to GMP/QSR and EU regulations pertaining to ISO9001/ISO13485/CMDR/CE and etc.
?Interface with regulatory agencies, customers and professional organizations in order to verify that corporate, site and departmental systems remain current and competitive.
1.Maintains and follows proper ISO procedures (ISO 9001, ISO 13485 2003, ISO 14971 and GMP requirements pertaining to medical devices/MDD);
2.Investigate, audit, analyze, propose improvements and manage processes in the Quality Management System;
3.Ensure that process requirements of 21 CFR 820, ISO13485 2003 & ISO 9001 are met;
4.Establish, organize & monitor the Quality Indicators Matrix;
5. Assists to Coordinate/manage training process;

7.Schedule and prepare management review meetings;
8.Assists assigned sites in the CAPA meeting, coordinate/manage CAPA efforts and interact with customers to conduct complaint investigations as necessary;
9.Coordinate and assist in activities relating to Global Quality & Regulatory Affairs
10.Provide Quality Management Systems assistance to all functional areas;
11.Assist during FDA inspections, Notified Body, customer audits and other third party Quality System evaluations;
12.Author, change and update Quality Manual and QA procedures as applicable.
13.Assists assigned sites to ensure overall Quality systems for all medical & healthcare work-cells are adequate.

ADDITIONAL DUTIES:
?Participate in project teams and meetings on behalf of the Global Quality & Regulatory Team in order to provide ideas, methods or processes for site/corporate performance improvement.
? Performs other job-related duties as assigned.
Position requires a 4-year degree in a technical/science area; an advanced degree is preferred. More then 6 years in a regulated industry with 3 or more years in a management position is also required. Significant experience with quality systems in a Medical device environment is also required. Incumbent must possess strong interpersonal and communication skills.

Mental Demands:
?Must be able to address questions from FDA investigators/Notified Body/Registrars auditors and customer auditor(s) by successfully communicating company's implementation of applicable regulations and standards (especially ISO13485 and 21 CFR 820).
?Incumbent must maintain up-to-date knowledge of all applicable regulations, guidelines and standards.
?Independent decision-making is expected for all routine business issues including interactions with the FDA, Notified Body, customers, etc. Must be able to assess the level of compliance in each area.

Supervision:
Direct: None at present time (this may change in the future)
Indirect: None at present time (this may change in the future)
Functional: Responsible for overseeing the Quality Plan, QSM and ensure timely processing of CAPAs. Also;
? Assists the site quality managers and other functional areas:
? Involved in developing, modifying and executing site and corporate policies which affect immediate operations and may also have company wide effect.

Responsibility:
This position will assist various sites (eg Singapore and Penang) as assigned to ensure that all QS activities are performed adequately. Therefore, the candidate must be prepared to travel to the sites when duties call for. The position is also responsible for making decisions that affect the product safety and efficacy and company's reputation in the market.

Contacts:
Internal: QA, QC and Regulatory Affairs management team, Operations team, Business Units as well as all other functional team members.
External: Industry peers, Regulatory agencies, Customers, Notified Body, FDA, Suppliers
Reports to: Sr. Director of Regulatory, Quality & Compliance, HC&LS (Health Care & life Sciences)

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