Keller Executive Search
Medical Device Quality Engineering Professional #1508
Keller Executive Search, Gallaway, Tennessee, us, 38036
Our client, a well-established producer of plastic medical devices, is looking for a Quality Engineering Professional to join their facility in Galloway, Tennessee. This presents an outstanding opportunity to develop and enhance essential quality operations within an FDA-regulated production setting.
The organization produces Class I and II medical device solutions including sterile packaging, patient care products, and biohazard containment items utilizing bag manufacturing and plastic injection molding technologies. Supported by a robust parent organization and operating across several locations, this position provides authentic advancement opportunities and the ability to significantly influence regulatory compliance and quality infrastructure.
Key Responsibilities
Manage CAPA (Corrective and Preventive Action) processes, including investigating customer complaints, performing root cause analysis, and verifying effectiveness of corrective measures
Supervise and guide Quality Assurance Auditors and Analysts in their daily quality assurance responsibilities
Support ongoing improvement programs throughout production operations
Facilitate the creation and upkeep of a robust Quality Management System (QMS) aligned with ISO 13485:2016 standards and FDA 21 CFR Part 820 (QSR) for Class I and II medical devices
Act as the quality point of contact with vendors and customers regarding quality issues
Conduct training sessions for cross-functional teams covering regulatory requirements, quality science, and statistical techniques
Monitor sterilization validation and regulatory adherence for medical device products sterilized by contract facilities
Direct and participate in external and internal quality audits, maintaining preparedness for regulatory inspections from FDA, Health Canada, and additional regulatory bodies
Maintain compliance with applicable regulatory requirements including AAMI sterilization standards, FDA, Health Canada, EPA, OSHA, and others
Deliver quality engineering assistance to manufacturing operations, including developing product specifications, ongoing evaluation, and analyzing data to verify products fulfill their intended purpose
Working knowledge of FDA 21 CFR Part 820 Quality System Regulation (QSR) - this is critical
Bachelor's degree from an accredited institution in Quality, Mechanical Engineering, or Industrial Engineering
Capability to lift and carry materials up to 50 pounds
Proficiency with database systems and Microsoft Office suite
ISO 13485:2016 Lead Auditor certification
Ability to function in a manufacturing setting (exposure to particulates from plastics processes, fumes, and noise)
2-4 years of experience in quality assurance engineering within a medical device manufacturing setting
Excellent communication abilities with capacity to engage effectively with senior leadership and shop floor staff
Background in blow molding and/or plastic injection molding manufacturing operations
Preferred Requirements
Knowledge of statistical methods and analysis of quality data
Experience managing vendor/customer quality relationships
Background overseeing sterilization validation processes
SAP proficiency
Experience performing root cause analysis in complaint investigations
Compensation & Benefits Salary Range:
$90,000 - $100,000
Benefits Package Includes:
Comprehensive health benefits
401(k) retirement plan
Paid leave days
Relocation assistance available
Equal Employment Opportunity and Non-Discrimination Policy
Equal Employment Opportunity Statement:
Both Keller Executive Search and our clients are Equal Opportunity Employers. For all positions, whether with Keller Executive Search or our clients, qualified applicants will receive consideration for employment without regard to race, skin color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran status, disability, genetic information, or any other legally protected status.
Commitment to Diversity:
Keller Executive Search and its clients are committed to fostering a diverse and inclusive work environment where all individuals are valued and respected.
Reasonable Accommodations:
Both Keller Executive Search and our clients are committed to providing reasonable accommodations to individuals with disabilities and pregnant individuals. We engage in an interactive process to determine effective, reasonable accommodations.
Compensation Information:
For client positions, compensation information is available in the job post. If not provided, it will be shared during the interview process in accordance with applicable laws. When required by law, salary ranges will be included in job postings. Actual salary may depend on skills, experience, and comparison to current employees in similar role. Salary ranges may vary: ...
Compliance with Laws:
Both Keller Executive Search and our clients comply with federal, state, ...
Workplace Harassment:
Both Keller Executive Search and our clients expressly prohibit ...
E-Verify Participation:
Keller Executive Search and/or ...
Privacy and Pay Equity:
California Residents: For more information about the categories of personal information we collect for recruiting and employment purposes, please review our Privacy Policy at www.kellerexecutivesearch.com.
Colorado, Nevada, New York City, California, and Washington Residents: Compensation information is available in the job post or will be provided during the interview process if not initially available.
Both Keller Executive Search and our clients are committed to pay equity and conduct periodic pay equity analyses in accordance with applicable laws.
State-Specific Information:
Rhode Island: We do not request or ...
Connecticut: We provide wage range ...
New Jersey ...
Veteran Status:
Both Keller Executive ...
Genetic Information:
In accordance ...
Local Laws:
...
Note:
This job posting may be for a position with Keller Executive Search or one ...
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The organization produces Class I and II medical device solutions including sterile packaging, patient care products, and biohazard containment items utilizing bag manufacturing and plastic injection molding technologies. Supported by a robust parent organization and operating across several locations, this position provides authentic advancement opportunities and the ability to significantly influence regulatory compliance and quality infrastructure.
Key Responsibilities
Manage CAPA (Corrective and Preventive Action) processes, including investigating customer complaints, performing root cause analysis, and verifying effectiveness of corrective measures
Supervise and guide Quality Assurance Auditors and Analysts in their daily quality assurance responsibilities
Support ongoing improvement programs throughout production operations
Facilitate the creation and upkeep of a robust Quality Management System (QMS) aligned with ISO 13485:2016 standards and FDA 21 CFR Part 820 (QSR) for Class I and II medical devices
Act as the quality point of contact with vendors and customers regarding quality issues
Conduct training sessions for cross-functional teams covering regulatory requirements, quality science, and statistical techniques
Monitor sterilization validation and regulatory adherence for medical device products sterilized by contract facilities
Direct and participate in external and internal quality audits, maintaining preparedness for regulatory inspections from FDA, Health Canada, and additional regulatory bodies
Maintain compliance with applicable regulatory requirements including AAMI sterilization standards, FDA, Health Canada, EPA, OSHA, and others
Deliver quality engineering assistance to manufacturing operations, including developing product specifications, ongoing evaluation, and analyzing data to verify products fulfill their intended purpose
Working knowledge of FDA 21 CFR Part 820 Quality System Regulation (QSR) - this is critical
Bachelor's degree from an accredited institution in Quality, Mechanical Engineering, or Industrial Engineering
Capability to lift and carry materials up to 50 pounds
Proficiency with database systems and Microsoft Office suite
ISO 13485:2016 Lead Auditor certification
Ability to function in a manufacturing setting (exposure to particulates from plastics processes, fumes, and noise)
2-4 years of experience in quality assurance engineering within a medical device manufacturing setting
Excellent communication abilities with capacity to engage effectively with senior leadership and shop floor staff
Background in blow molding and/or plastic injection molding manufacturing operations
Preferred Requirements
Knowledge of statistical methods and analysis of quality data
Experience managing vendor/customer quality relationships
Background overseeing sterilization validation processes
SAP proficiency
Experience performing root cause analysis in complaint investigations
Compensation & Benefits Salary Range:
$90,000 - $100,000
Benefits Package Includes:
Comprehensive health benefits
401(k) retirement plan
Paid leave days
Relocation assistance available
Equal Employment Opportunity and Non-Discrimination Policy
Equal Employment Opportunity Statement:
Both Keller Executive Search and our clients are Equal Opportunity Employers. For all positions, whether with Keller Executive Search or our clients, qualified applicants will receive consideration for employment without regard to race, skin color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran status, disability, genetic information, or any other legally protected status.
Commitment to Diversity:
Keller Executive Search and its clients are committed to fostering a diverse and inclusive work environment where all individuals are valued and respected.
Reasonable Accommodations:
Both Keller Executive Search and our clients are committed to providing reasonable accommodations to individuals with disabilities and pregnant individuals. We engage in an interactive process to determine effective, reasonable accommodations.
Compensation Information:
For client positions, compensation information is available in the job post. If not provided, it will be shared during the interview process in accordance with applicable laws. When required by law, salary ranges will be included in job postings. Actual salary may depend on skills, experience, and comparison to current employees in similar role. Salary ranges may vary: ...
Compliance with Laws:
Both Keller Executive Search and our clients comply with federal, state, ...
Workplace Harassment:
Both Keller Executive Search and our clients expressly prohibit ...
E-Verify Participation:
Keller Executive Search and/or ...
Privacy and Pay Equity:
California Residents: For more information about the categories of personal information we collect for recruiting and employment purposes, please review our Privacy Policy at www.kellerexecutivesearch.com.
Colorado, Nevada, New York City, California, and Washington Residents: Compensation information is available in the job post or will be provided during the interview process if not initially available.
Both Keller Executive Search and our clients are committed to pay equity and conduct periodic pay equity analyses in accordance with applicable laws.
State-Specific Information:
Rhode Island: We do not request or ...
Connecticut: We provide wage range ...
New Jersey ...
Veteran Status:
Both Keller Executive ...
Genetic Information:
In accordance ...
Local Laws:
...
Note:
This job posting may be for a position with Keller Executive Search or one ...
#J-18808-Ljbffr