Quality Assurance Manager/Director
Centrix Centrix Shelton, CT Shelton, CT Full-time Full-time $115,000 - $160,000 a year $115,000 - $160,000 a year 4 days ago 4 days ago 4 days ago Job Title:
Quality Assurance Manager/Director Onsite:
Shelton, CT USA (local candidates only) POSITION
Summary:
The primary job function of the Quality Assurance Manager is to design, implement, maintain, and provide the day-to-day management of the Centrix Quality Management System (QMS).
This position will ensure that all required processes and procedures are established and maintained to meet FDA and international medical device compliance requirements.
These responsibilities include the supervision of a Quality Control inspection team.
The QA Manager will also support the Management Representative and Person Responsible for Regulatory Compliance as needed.
Essential Functions:
Document Control:
administrator of all controlled documents; ensures proper processing, retrieval and storage of all new and revised documents Change Control:
member of Change Control team; ensures each change order properly documented Complaint Processing:
lead complaint investigator; ensures complaint investigations are completed in a thorough and timely manner.
Performs Adverse Event/MDR review of each complaint report; performs monthly trend analysis Non-Conformances:
dispositions and approved all non-conformances; ensures nonconformances are processed in a thorough and timely manner; performs monthly trend analysis Supplier Control:
reviews and approves all suppliers for Approved Supplier List; performs supplier reviews to established schedule CAPAs:
member of CAPA team; responsible for coordinating inter-departmental root cause and corrective action activities; ensures CAPAs are completed in a thorough and timely manner; performs monthly trend analysis Internal Audits:
schedules all internal audit activities using approved supplier; provides audit response and corrective actions as required Calibration:
administrator of all calibrated equipment; ensures proper processing of new and current equipment to established procedures using approved suppliers Training:
primary GMP trainer and promoter of Quality awareness throughout Company Supervision:
Manager of Quality Control Inspectors for Incoming, In-process and Final inspection of Centrix products Other duties as assigned QUALIFICATIONS, SKILLS, ABILITIES REQUIRED:
Practical knowledge in various inspection and sampling techniques Practical knowledge in Microsoft programs to record/trend inspection results Practical knowledge in applying and integrating relevant MDSAP, ISO 13485 and FDA GMP's requirements to regulated processes Persuasive communication skills, both oral and written, to ensure continuous quality improvement throughout the Company Pro-active mindset using well-organized and detail-oriented plans to effect change as necessary EDUCATION, EXPERIENCE REQUIRED:
Must have medical device experience 5-10 years in a device manufacturing environment with similar quality responsibilities Minimum 3 years management/supervisory experience Solid technical writing
Experience:
MS project and MS Access are a plus Degree in Sciences, preferred Quality and/or Regulatory Certification a plus The listed salary range serves as a guide and the salary offered within that range to the candidate selected will be based on experience, qualifications, and location.
Salary range is $115,000 - $160,000.
Job Type:
Full-time Pay:
$115,000.
00 - $160,000.
00 per year
Benefits:
401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Life insurance Paid time off Vision insurance Schedule:
8 hour shift Monday to Friday Work Location:
In person Document Control:
administrator of all controlled documents; ensures proper processing, retrieval and storage of all new and revised documents Change Control:
member of Change Control team; ensures each change order properly documented Complaint Processing:
lead complaint investigator; ensures complaint investigations are completed in a thorough and timely manner.
Performs Adverse Event/MDR review of each complaint report; performs monthly trend analysis Non-Conformances:
dispositions and approved all non-conformances; ensures nonconformances are processed in a thorough and timely manner; performs monthly trend analysis Supplier Control:
reviews and approves all suppliers for Approved Supplier List; performs supplier reviews to established schedule CAPAs:
member of CAPA team; responsible for coordinating inter-departmental root cause and corrective action activities; ensures CAPAs are completed in a thorough and timely manner; performs monthly trend analysis Internal Audits:
schedules all internal audit activities using approved supplier; provides audit response and corrective actions as required Calibration:
administrator of all calibrated equipment; ensures proper processing of new and current equipment to established procedures using approved suppliers Training:
primary GMP trainer and promoter of Quality awareness throughout Company Supervision:
Manager of Quality Control Inspectors for Incoming, In-process and Final inspection of Centrix products Other duties as assigned Practical knowledge in various inspection and sampling techniques Practical knowledge in Microsoft programs to record/trend inspection results Practical knowledge in applying and integrating relevant MDSAP, ISO 13485 and FDA GMP's requirements to regulated processes Persuasive communication skills, both oral and written, to ensure continuous quality improvement throughout the Company Pro-active mindset using well-organized and detail-oriented plans to effect change as necessary Must have medical device experience 5-10 years in a device manufacturing environment with similar quality responsibilities Minimum 3 years management/supervisory experience Solid technical writing
Experience:
MS project and MS Access are a plus Degree in Sciences, preferred Quality and/or Regulatory Certification a plus 401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Life insurance Paid time off Vision insurance 8 hour shift Monday to Friday.
Estimated Salary: $20 to $28 per hour based on qualifications.
Quality Assurance Manager/Director Onsite:
Shelton, CT USA (local candidates only) POSITION
Summary:
The primary job function of the Quality Assurance Manager is to design, implement, maintain, and provide the day-to-day management of the Centrix Quality Management System (QMS).
This position will ensure that all required processes and procedures are established and maintained to meet FDA and international medical device compliance requirements.
These responsibilities include the supervision of a Quality Control inspection team.
The QA Manager will also support the Management Representative and Person Responsible for Regulatory Compliance as needed.
Essential Functions:
Document Control:
administrator of all controlled documents; ensures proper processing, retrieval and storage of all new and revised documents Change Control:
member of Change Control team; ensures each change order properly documented Complaint Processing:
lead complaint investigator; ensures complaint investigations are completed in a thorough and timely manner.
Performs Adverse Event/MDR review of each complaint report; performs monthly trend analysis Non-Conformances:
dispositions and approved all non-conformances; ensures nonconformances are processed in a thorough and timely manner; performs monthly trend analysis Supplier Control:
reviews and approves all suppliers for Approved Supplier List; performs supplier reviews to established schedule CAPAs:
member of CAPA team; responsible for coordinating inter-departmental root cause and corrective action activities; ensures CAPAs are completed in a thorough and timely manner; performs monthly trend analysis Internal Audits:
schedules all internal audit activities using approved supplier; provides audit response and corrective actions as required Calibration:
administrator of all calibrated equipment; ensures proper processing of new and current equipment to established procedures using approved suppliers Training:
primary GMP trainer and promoter of Quality awareness throughout Company Supervision:
Manager of Quality Control Inspectors for Incoming, In-process and Final inspection of Centrix products Other duties as assigned QUALIFICATIONS, SKILLS, ABILITIES REQUIRED:
Practical knowledge in various inspection and sampling techniques Practical knowledge in Microsoft programs to record/trend inspection results Practical knowledge in applying and integrating relevant MDSAP, ISO 13485 and FDA GMP's requirements to regulated processes Persuasive communication skills, both oral and written, to ensure continuous quality improvement throughout the Company Pro-active mindset using well-organized and detail-oriented plans to effect change as necessary EDUCATION, EXPERIENCE REQUIRED:
Must have medical device experience 5-10 years in a device manufacturing environment with similar quality responsibilities Minimum 3 years management/supervisory experience Solid technical writing
Experience:
MS project and MS Access are a plus Degree in Sciences, preferred Quality and/or Regulatory Certification a plus The listed salary range serves as a guide and the salary offered within that range to the candidate selected will be based on experience, qualifications, and location.
Salary range is $115,000 - $160,000.
Job Type:
Full-time Pay:
$115,000.
00 - $160,000.
00 per year
Benefits:
401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Life insurance Paid time off Vision insurance Schedule:
8 hour shift Monday to Friday Work Location:
In person Document Control:
administrator of all controlled documents; ensures proper processing, retrieval and storage of all new and revised documents Change Control:
member of Change Control team; ensures each change order properly documented Complaint Processing:
lead complaint investigator; ensures complaint investigations are completed in a thorough and timely manner.
Performs Adverse Event/MDR review of each complaint report; performs monthly trend analysis Non-Conformances:
dispositions and approved all non-conformances; ensures nonconformances are processed in a thorough and timely manner; performs monthly trend analysis Supplier Control:
reviews and approves all suppliers for Approved Supplier List; performs supplier reviews to established schedule CAPAs:
member of CAPA team; responsible for coordinating inter-departmental root cause and corrective action activities; ensures CAPAs are completed in a thorough and timely manner; performs monthly trend analysis Internal Audits:
schedules all internal audit activities using approved supplier; provides audit response and corrective actions as required Calibration:
administrator of all calibrated equipment; ensures proper processing of new and current equipment to established procedures using approved suppliers Training:
primary GMP trainer and promoter of Quality awareness throughout Company Supervision:
Manager of Quality Control Inspectors for Incoming, In-process and Final inspection of Centrix products Other duties as assigned Practical knowledge in various inspection and sampling techniques Practical knowledge in Microsoft programs to record/trend inspection results Practical knowledge in applying and integrating relevant MDSAP, ISO 13485 and FDA GMP's requirements to regulated processes Persuasive communication skills, both oral and written, to ensure continuous quality improvement throughout the Company Pro-active mindset using well-organized and detail-oriented plans to effect change as necessary Must have medical device experience 5-10 years in a device manufacturing environment with similar quality responsibilities Minimum 3 years management/supervisory experience Solid technical writing
Experience:
MS project and MS Access are a plus Degree in Sciences, preferred Quality and/or Regulatory Certification a plus 401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Life insurance Paid time off Vision insurance 8 hour shift Monday to Friday.
Estimated Salary: $20 to $28 per hour based on qualifications.
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