SENIOR COMPLIANCE SPECIALIST-00000T5H
Description
General Job Description:
To provide support to plants in relation to compliance with applicable regulations, standards and J & J requirements.
Main responsibilities
- Maintains formalized audit schedule and internal audit program
- Participates in audits performed by CQA, EES Corporate, and other external agencies.
- Participates in identifying issues and determining corrective actions in relation to applicable regulations, standards and J & J requirements..
-
- Follows all company safety policies and other safety precautions within the work area
- Compliance with safety policies and procedures
- Ensures compliance with Environmental Management System (EMS) responsibilities
- Follow J&J and EES Records Management Policies for Convenience Information, Records Retention Schedules, Training and Education, Document Hold Notices, Records Cleanout, Inactive Records and Information Management, Vital Records and third party vendor if applicable.
- Other responsibilities may be assigned and not all responsibilities listed may be assigned
Reporting to: MANAGER QUALITY COMPLIANCE CDM / BWI / EES
Qualifications
EDUCATION AND JOB EXPERIENCE REQUIREMENTS:
- Bachelor of Science in Engineering or applied Science
- Bilingual: English/ Spanish.
- ISO knowledge (e.g. ISO 13485:2003, etc.) preferred
- Knowledge of FDA requirements (e.g. 21 CFRPart 820) preferred
- MDD: 93/42/EEC Knowledge preferred
- Medical Device Regulations (Canada) Knowledge preferred
- PC proficiency
- Five years quality systems or regulatory affairs experience
- Experience in medical product industry preferred
Global Leadership Profile Competencies
Integrity and Credo-based Actions ~ lives Credo values; builds trust; tells the truth; initiates transparency into problems; demonstrates genuine caring for people
Collaboration and Teaming ~ puts interests of enterprise above own; works well across functions and groups; builds teams effectively; inspires follower ship; instills a global mindset
Results and Performance Driven ~ assumes personal ownership and accountability for business results and solutions; willing to make tough calls; consistently delivers results that meet or exceed expectations; demonstrates a track record of people development; champions diversity; net exporter of successful talent.
Sense of Urgency ~ proactively senses and responds to problems and opportunities; works to reduce "cycle" time; takes action when needed
Organization:
EES, SA DE CV
Apply until: Septiembre 18, 2014
Primary Location:Latin America-Mexico-Chihuahua-Juarez
Organization: E.E.S., S.A. de C.V. Mexico (8283)
Job Function: Quality Control
Description
General Job Description:
To provide support to plants in relation to compliance with applicable regulations, standards and J & J requirements.
Main responsibilities
- Maintains formalized audit schedule and internal
- Participates in audits performed by CQA, EES Corporate, and other external agencies.
- Participates in identifying issues and determining corrective actions in relation to
-
- Follows all company safety policies and other safety precautions within the work area
- Compliance with safety policies and procedures
- Ensures compliance with Environmental Management System (EMS) responsibilities
- Follow J&J and EES Records Management Policies for Convenience Information, Records Retention Schedules, Training and Education, Document Hold Notices, Records Cleanout, Inactive Records and Information Management, Vital Records and third party vendor if applicable.
- Other responsibilities may be assigned and not all responsibilities listed may be assigned
Reporting to: MANAGER QUALITY COMPLIANCE CDM / BWI / EES
Qualifications
EDUCATION AND JOB EXPERIENCE REQUIREMENTS:
- Bachelor of Science in Engineering or applied Science
- Bilingual: English/ Spanish.
- ISO knowledge (e.g. ISO 13485:2003, etc.) preferred
- Knowledge of FDA requirements (e.g. 21 CFR
- MDD: 93/42/EEC Knowledge preferred
- Medical Device Regulations (Canada) Knowledge preferred
- PC proficiency
- Five years quality systems or regulatory affairs experience
- Experience in medical product industry preferred
Global Leadership Profile Competencies
Integrity and Credo-based Actions ~ lives Credo values; builds trust; tells the truth; initiates transparency into problems; demonstrates genuine caring for people
Collaboration and Teaming ~ puts interests of enterprise above own; works well across functions and groups; builds teams effectively; inspires follower ship; instills a global mindset
Results and Performance Driven ~ assumes personal ownership and accountability for business results and solutions; willing to make tough calls; consistently delivers results that meet or exceed expectations; demonstrates a track record of people development; champions diversity; net exporter of successful talent.
Sense of Urgency ~ proactively senses and responds to problems and opportunities; works to reduce "cycle" time; takes action when needed
Organization:
EES, SA DE CV
Apply until: Septiembre 18, 2014
Primary Location:Latin America-Mexico-Chihuahua-Juarez
Organization: E.E.S., S.A. de C.V. Mexico (8283)
Job Function: Quality Control