Intellectt Inc
Overview
The ideal candidate will lead and execute quality and process validation activities across manufacturing operations, ensuring compliance with regulatory standards and continuous process improvement. This position focuses on developing validation protocols, conducting PFMEAs, and ensuring test methods are accurate, repeatable, and compliant with industry regulations. Responsibilities
Develop, execute, and document
process validation plans (IQ/OQ/PQ)
for new and existing manufacturing processes. Lead and facilitate
Process Failure Modes and Effects Analysis (PFMEA)
sessions to identify, assess, and mitigate risks. Design, validate, and maintain
test methods
to ensure accuracy, repeatability, and compliance with industry standards. Collaborate with cross-functional teams—Quality, Engineering, and Manufacturing—to drive
continuous improvement
and ensure process consistency. Analyze data from validation studies and recommend process enhancements based on statistical findings. Prepare and maintain detailed
validation reports, SOPs, and work instructions
in alignment with internal and regulatory requirements. Support root cause analysis and implementation of corrective and preventive actions (CAPA) as needed. Required Qualifications
Bachelor’s degree
in Engineering, Science, or related technical field. 7+ years of experience
in process validation or quality engineering within the
medical device manufacturing
industry. Proven expertise in
IQ/OQ/PQ
validation and
PFMEA
facilitation. Strong background in
Quality Systems
and regulatory compliance ( FDA ,
ISO 13485 ). Experience with
orthopedic devices
is highly preferred. Preferred Qualifications
Experience in
test method validation
and statistical techniques (e.g., Gage R&R, DOE). Familiarity with
CAPA systems, risk management (ISO 14971) , and continuous improvement methodologies (Lean, Six Sigma). Seniority level
Mid-Senior level Employment type
Contract Job function
Engineering and Quality Assurance Industries
Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research Location: Methuen, MA. Salary ranges provided in listing: $120,000.00-$150,000.00.
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The ideal candidate will lead and execute quality and process validation activities across manufacturing operations, ensuring compliance with regulatory standards and continuous process improvement. This position focuses on developing validation protocols, conducting PFMEAs, and ensuring test methods are accurate, repeatable, and compliant with industry regulations. Responsibilities
Develop, execute, and document
process validation plans (IQ/OQ/PQ)
for new and existing manufacturing processes. Lead and facilitate
Process Failure Modes and Effects Analysis (PFMEA)
sessions to identify, assess, and mitigate risks. Design, validate, and maintain
test methods
to ensure accuracy, repeatability, and compliance with industry standards. Collaborate with cross-functional teams—Quality, Engineering, and Manufacturing—to drive
continuous improvement
and ensure process consistency. Analyze data from validation studies and recommend process enhancements based on statistical findings. Prepare and maintain detailed
validation reports, SOPs, and work instructions
in alignment with internal and regulatory requirements. Support root cause analysis and implementation of corrective and preventive actions (CAPA) as needed. Required Qualifications
Bachelor’s degree
in Engineering, Science, or related technical field. 7+ years of experience
in process validation or quality engineering within the
medical device manufacturing
industry. Proven expertise in
IQ/OQ/PQ
validation and
PFMEA
facilitation. Strong background in
Quality Systems
and regulatory compliance ( FDA ,
ISO 13485 ). Experience with
orthopedic devices
is highly preferred. Preferred Qualifications
Experience in
test method validation
and statistical techniques (e.g., Gage R&R, DOE). Familiarity with
CAPA systems, risk management (ISO 14971) , and continuous improvement methodologies (Lean, Six Sigma). Seniority level
Mid-Senior level Employment type
Contract Job function
Engineering and Quality Assurance Industries
Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research Location: Methuen, MA. Salary ranges provided in listing: $120,000.00-$150,000.00.
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