Dear Business Partner,
Hope you are doing well today,
Please review the requirement and let me know if you have any one available
for the below position, Please send me your consultant updated resume with
the contact detail ASAP

Job Title: Quality Analyst
Location:  Bates ville, IN
Duration:  Full time position

//////// Need US Citizen OR Green Card Only ////////

QUALIFICATIONS:
Thorough working knowledge and understanding of medical device regulations
and standards, including but not limited to QSR, CMDR, Medical Device
Directive, ISO Quality System and other applicable industry requirements is
required.
Excellent verbal and written communication skills, including attention to
detail; strong questioning and listening skills; and the ability to look
beyond obvious answers in order to understand the impact on other areas is
required.
Must have ability to make effective presentations to all levels of the
organization.
Proven ability to prioritize and manage multiple projects and meet
deadlines.
Excellent organizational skills and ability to plan and implement
resolutions to problems.
Ability to communicate between various organizations and work with
multifunctional teams.
Strong appreciation of the impact of regulatory bodies on medical device
product lifecycle is required.
Experience working with diverse cultures and employees.
ASQ Certifications for Auditing and/or Quality Management is a plus.
May involve seldom (less than 5%) overnight travel based on business needs.
May involve minimal bending and lifting.

EDUCATION AND/OR EXPERIENCE:
Bachelor's degree in a related medical, science, or regulatory discipline
required.
5+ years in the medical device industry or related GMP environment or
equivalent.
3+ years of experience with cGMP quality system regulations and
investigations.
3+ years of experience working with and leading cross-functional teams.
Prior experience with document control, CAPA management, and internal
auditing is preferred.
Experience with Six Sigma Process Excellence tools, training and/or
certification is a plus.
Experience with documentation and technical writing skills, in a regulated
compliance environment, is preferred.
Demonstrated strong proficiency with Microsoft systems (Excel, PowerPoint,
Word, and Project) and Agile

Warm Regards,
Steven Smith.

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