The Manager, Quality Assurance is a key member of the facility
management team; and manages the total quality program, policies, and
initiatives. Responsible for identifying, analysing, reporting, and
developing improvements in productivity, quality and customer
relationships, and customer service. Serves as a process expert in
their area of responsibility.
Duties
* Perform final quality assurance review and release of all products
manufactured, assembled, and/or distributed by the facility.
* Must be familiar with all processes, equipment and products utilized
throughout the designated facility. Become the facility Process
Expert.
* Monitor and ensure compliance with the quality assurance program
established by the company to meet FDA and other applicable regulatory
guidelines. Ensure that the requirements of **Apply on the website**
CFR **Apply on the website** are implemented and maintained.
* Maintain product complaint system at facility level. Responsible for
researching complaints, developing a corrective action plan in
conjunction with facility management, implementing the plan and
communicating corrective action responses to customers.
* Complete and maintain accurate records of all quality assurance
programs established by the company and required by designated area of
responsibility, the FDA or other regulatory body.
* Participate as part of the facility management team to identify
document and investigate non-conformance issues at the facility,
ensuring that appropriate corrective measures are implemented and
monitored.
* Maintain the facility CAPA system and appropriate documentation.
* Interface with operations and engineering to assure Q. A. aspects
are addressed with equipment changes/modifications.
* Conduct GMP, blood borne pathogen and other training programs as
required.
* Performs periodic quality systems audits, and generates audit
reports. Maintain the facility internal audit program.
* Generate reports and data analysis as required by SVP Process
Engineering & QA and the RA Manager.
* Provide support to the Sales Team on Customer Issue Resolution and
the presentation of Quality Metrics (BRs).
* Responsible for the supervision and management of the
facility&#**Apply on the website**;s QA Technicians team.
Required Experience
* B.S. degree preferred. Experience in Medical device, pharmaceutical,
food/beverage Q. A. or other FDA regulated industries may be
considered a substitute for education. High School diploma or GED
required.
* Minimum of 2 years&#**Apply on the website**; experience working in
a Medical device or quality related field required.
* Proficient with word processing and spreadsheet programs including
some basic charting, graphing and data compilations.
* Excellent verbal, written communication and mathematical skills
required.
* Strong computer skills required, excellent working knowledge of MS
Word, MS Excel. Proficient with word processing and spreadsheet
programs including some basic charting, graphing and data
compilations.
* Ability to interface with all levels of management.
* Ability to understand and interpret written requirements to assure
adherence to documented procedures.
* Experience in problem solving and root cause analysis.
* Ability to interpret and implement device GMP&#**Apply on the
website**;s.
Preferred Experience
* Certified Quality Auditor and or Certified Quality Engineer
preferred
* Experience working with device GMP preferred.
* Experience with an instrument tracking system preferred.
* Experience with business&#**Apply on the website**;s current
operating software preferred.
* Lean Six Sigma experience preferred Location: Not Specified
The Manager, Quality Assurance is a key member of the facility
management team; and manages the total quality program, policies, and
initiatives. Responsible for identifying, analysing, reporting, and
developing improvements in productivity, quality and customer
relationships, and customer service. Serves as a process expert in
their area of responsibility.
Duties
* Perform final quality assurance review and release of all products
manufactured, assembled, and/or distributed by the facility.
* Must be familiar with all processes, equipment and products utilized
throughout the designated facility. Become the facility Process
Expert.
* Monitor and ensure compliance with the quality assurance program
established by the company to meet FDA and other applicable regulatory
guidelines. Ensure that the requirements of **Apply on the website**
CFR **Apply on the website** are implemented and maintained.
* Maintain product complaint system at facility level. Responsible for
researching complaints, developing a corrective action plan in
conjunction with facility management, implementing the plan and
communicating corrective action responses to customers.
* Complete and maintain accurate records of all quality assurance
programs established by the company and required by designated area of
responsibility, the FDA or other regulatory body.
* Participate as part of the facility management team to identify
document and investigate non-conformance issues at the facility,
ensuring that appropriate corrective measures are implemented and
monitored.
* Maintain the facility CAPA system and appropriate documentation.
* Interface with operations and engineering to assure Q. A. aspects
are addressed with equipment changes/modifications.
* Conduct GMP, blood borne pathogen and other training programs as
required.
* Performs periodic quality systems audits, and generates audit
reports. Maintain the facility internal audit program.
* Generate reports and data analysis as required by SVP Process
Engineering & QA and the RA Manager.
* Provide support to the Sales Team on Customer Issue Resolution and
the presentation of Quality Metrics (BRs).
* Responsible for the supervision and management of the
facility&#**Apply on the website**;s QA Technicians team.
Required Experience
* B.S. degree preferred. Experience in Medical device, pharmaceutical,
food/beverage Q. A. or other FDA regulated industries may be
considered a substitute for education. High School diploma or GED
required.
* Minimum of 2 years&#**Apply on the website**; experience working in
a Medical device or quality related field required.
* Proficient with word processing and spreadsheet programs including
some basic charting, graphing and data compilations.
* Excellent verbal, written communication and mathematical skills
required.
* Strong computer skills required, excellent working knowledge of MS
Word, MS Excel. Proficient with word processing and spreadsheet
programs including some basic charting, graphing and data
compilations.
* Ability to interface with all levels of management.
* Ability to understand and interpret written requirements to assure
adherence to documented procedures.
* Experience in problem solving and root cause analysis.
* Ability to interpret and implement device GMP&#**Apply on the
website**;s.
Preferred Experience
* Certified Quality Auditor and or Certified Quality Engineer
preferred
* Experience working with device GMP preferred.
* Experience with an instrument tracking system preferred.
* Experience with business&#**Apply on the website**;s current
operating software preferred.
* Lean Six Sigma experience preferred
We need : English (Good)
Type: Permanent
Payment:
Category: Others
