Keller Executive Search
Quality Assurance Engineer (Medical Device Manufacture)
Keller Executive Search, Gallaway, Tennessee, us, 38036
Our client, a well-established medical device manufacturer specializing in plastic medical products, is seeking a Quality Assurance Engineer to join their team in Galloway, Tennessee. This is an exciting opportunity to build and strengthen a critical quality function within a FDA-regulated manufacturing environment.
The company manufactures Class I and II medical device products including biohazard containment, patient care items, and sterile packaging solutions through plastic injection molding and bag manufacturing processes. With facilities across multiple states and a strong parent company backing, this role offers genuine growth potential and the chance to make a meaningful impact on quality systems and regulatory compliance.
Key Responsibilities
Support the development and maintenance of a comprehensive Quality Management System (QMS) compliant with FDA 21 CFR Part 820 (QSR) and ISO 13485:2016 standards for Class I and II medical devices Lead and participate in internal and external quality audits, ensuring readiness for FDA, Health Canada, and other regulatory inspections Manage CAPA (Corrective and Preventive Action) systems, including root cause analysis, investigation of customer complaints, and effectiveness verification Oversee sterilization validation and compliance for contract-sterilized medical device products Provide quality engineering support to production, including product specification development, continuous evaluation, and data analysis to ensure products meet intended use Serve as quality liaison with customers and vendors on quality-related matters Deliver training to cross-functional teams on statistical techniques, quality science, and regulatory requirements Supervise and direct Quality Assurance Analysts and Auditors in day-to-day quality assurance activities Ensure compliance with FDA, Health Canada, AAMI sterilization standards, OSHA, EPA, and other applicable regulatory requirements Support continuous improvement initiatives across manufacturing operations Bachelor's degree in Industrial Engineering, Mechanical Engineering, or Quality from an accredited institution Experience with plastic injection molding and/or blow molding manufacturing processes ISO 13485:2016 Lead Auditor certification 2-4 years of quality assurance engineering experience in a medical device manufacturing environment Working knowledge of FDA 21 CFR Part 820 Quality System Regulation (QSR) - this is essential Strong communication skills with the ability to interact effectively with both shop floor personnel and senior leadership Computer proficiency in Microsoft Office suite and experience with database systems Ability to work in a manufacturing environment (noise, fumes, particulates from plastics processes) Ability to lift and carry items up to 50 pounds Preferred Requirements
SAP proficiency Experience with vendor/customer quality management Background in sterilization validation oversight Experience conducting complaint investigations with root cause analysis Familiarity with statistical methods and quality data analysis 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 roles. Salary ranges may vary based on role and location. Compliance with Laws:
Both Keller Executive Search and our clients comply with federal, state, and local laws governing nondiscrimination in employment. This policy applies to all employment terms and conditions, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Workplace Harassment:
Both Keller Executive Search and our clients expressly prohibit any form of workplace harassment based on race, skin color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. E-Verify Participation:
Keller Executive Search and/or our clients may participate in E-Verify. Information about E-Verify participation will be provided during the application process where applicable. 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 require salary history from applicants. Connecticut: We provide wage range information upon request or before discussing compensation. New Jersey: We do not inquire about salary history unless voluntarily disclosed. Veteran Status:
Both Keller Executive Search and our clients provide equal employment opportunities to veterans and comply with applicable state laws regarding veteran preference in employment. If you are a veteran, please inform us during the application process. Genetic Information:
In accordance with federal and state laws, both Keller Executive Search and our clients do not discriminate based on genetic information. We do not request or require genetic information from applicants or employees, except as permitted by law. Local Laws:
Both Keller Executive Search and our clients comply with all applicable local laws and ordinances regarding employment practices in the areas where we operate. Note:
This job posting may be for a position with Keller Executive Search or one of our clients. The specific employer will be identified during the application and interview process. Employment laws and requirements may vary depending on the employer and location.
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Support the development and maintenance of a comprehensive Quality Management System (QMS) compliant with FDA 21 CFR Part 820 (QSR) and ISO 13485:2016 standards for Class I and II medical devices Lead and participate in internal and external quality audits, ensuring readiness for FDA, Health Canada, and other regulatory inspections Manage CAPA (Corrective and Preventive Action) systems, including root cause analysis, investigation of customer complaints, and effectiveness verification Oversee sterilization validation and compliance for contract-sterilized medical device products Provide quality engineering support to production, including product specification development, continuous evaluation, and data analysis to ensure products meet intended use Serve as quality liaison with customers and vendors on quality-related matters Deliver training to cross-functional teams on statistical techniques, quality science, and regulatory requirements Supervise and direct Quality Assurance Analysts and Auditors in day-to-day quality assurance activities Ensure compliance with FDA, Health Canada, AAMI sterilization standards, OSHA, EPA, and other applicable regulatory requirements Support continuous improvement initiatives across manufacturing operations Bachelor's degree in Industrial Engineering, Mechanical Engineering, or Quality from an accredited institution Experience with plastic injection molding and/or blow molding manufacturing processes ISO 13485:2016 Lead Auditor certification 2-4 years of quality assurance engineering experience in a medical device manufacturing environment Working knowledge of FDA 21 CFR Part 820 Quality System Regulation (QSR) - this is essential Strong communication skills with the ability to interact effectively with both shop floor personnel and senior leadership Computer proficiency in Microsoft Office suite and experience with database systems Ability to work in a manufacturing environment (noise, fumes, particulates from plastics processes) Ability to lift and carry items up to 50 pounds Preferred Requirements
SAP proficiency Experience with vendor/customer quality management Background in sterilization validation oversight Experience conducting complaint investigations with root cause analysis Familiarity with statistical methods and quality data analysis 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 roles. Salary ranges may vary based on role and location. Compliance with Laws:
Both Keller Executive Search and our clients comply with federal, state, and local laws governing nondiscrimination in employment. This policy applies to all employment terms and conditions, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Workplace Harassment:
Both Keller Executive Search and our clients expressly prohibit any form of workplace harassment based on race, skin color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. E-Verify Participation:
Keller Executive Search and/or our clients may participate in E-Verify. Information about E-Verify participation will be provided during the application process where applicable. 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 require salary history from applicants. Connecticut: We provide wage range information upon request or before discussing compensation. New Jersey: We do not inquire about salary history unless voluntarily disclosed. Veteran Status:
Both Keller Executive Search and our clients provide equal employment opportunities to veterans and comply with applicable state laws regarding veteran preference in employment. If you are a veteran, please inform us during the application process. Genetic Information:
In accordance with federal and state laws, both Keller Executive Search and our clients do not discriminate based on genetic information. We do not request or require genetic information from applicants or employees, except as permitted by law. Local Laws:
Both Keller Executive Search and our clients comply with all applicable local laws and ordinances regarding employment practices in the areas where we operate. Note:
This job posting may be for a position with Keller Executive Search or one of our clients. The specific employer will be identified during the application and interview process. Employment laws and requirements may vary depending on the employer and location.
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