Senior Quality Systems Engineer

Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make: As a Sr. Quality Systems Engineer, you will support and enhance the administration of quality systems within our Lexington facility. You will manage core quality processes, coordinate internal and external audits, and report on quality system metrics. Your work will help maintain compliance with global regulations and foster a strong culture of quality throughout the organization.
Responsibilities:
Quality System Management
• Own the Change Control system, including reviewing and completing impact assessments.
• Execute CAPAs (Corrective and Preventive Actions) and manage the CAPA system as needed, ensuring timely investigations, thorough root cause analysis, and implementation of effective solutions to address quality issues.
• Lead continuous improvement initiatives to enhance the efficiency and effectiveness of quality systems and processes, ensuring compliance with applicable regulations.
• Oversee internal and external audit processes, including hosting, responding, and executing internal audits.
• Develop and maintain metrics and trend reports on quality system effectiveness (e.g., CAPA status, audit outcomes, supplier performance). Provide regular updates to management.
• Develop and implement training programs for the Quality Systems team, ensuring staff are adequately trained on quality systems, regulatory requirements, and internal procedures.
• Prepare APQRs (Annual Product Quality Reviews) by collecting, analyzing, and reporting required data in compliance with regulatory expectations.
• Promote a culture of quality and compliance across the organization.
• Ensure assigned quality systems comply with applicable regulations such as FDA (Food and Drug Administration), EU (European Union), PIC/S (Pharmaceutical Inspection Co-operation Scheme), Health Canada, and 21 CFR Parts 820, 210, and 211. Stay current on regulatory changes.
• Collaborate with Manufacturing, R&D, and Supply Chain teams to support effective quality system implementation throughout the product lifecycle.
• Lead or support activities associated with one-time or ongoing projects, ranging from participation to project management.
• Support the development and maintenance of Quality Systems as appropriate.
• Perform other duties as assigned to support the overall quality management system and business objectives.

Qualifications:
• Bachelor’s degree in Engineering, Mathematics, or Computer Science (Master’s preferred). Equivalent experience may be considered in place of education.
• 5+ years of manufacturing or relevant experience in the pharmaceutical/medical device cGMP (current Good Manufacturing Practice) industries; or 3+ years' experience in the pharmaceutical industry and a Master's degree.
• Proven ability to assess problems, identify solutions, and implement necessary changes.
• Experience in quality systems (internal and/or external) preferred.
• Familiarity with eQMS (MasterControl or Veeva) preferred.
• Ability to work both independently and in a team-oriented environment.
• Strong organizational skills with the ability to manage multiple tasks and meet deadlines.
• Well-developed written and verbal communication skills, including technical writing.
• Qualified to work with controlled substances.

Physical Requirements:
• Regular use of hands to handle computerized systems and training materials.
• Extended periods of computer use daily.
• Frequent use of the telephone and electronic communication tools.
• Regular standing and walking for extended periods.
• Occasional lifting or moving of up to 25 pounds.
• Must use proper lifting techniques and maintain awareness of workplace hazards.
• Required to follow all site safety procedures

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Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any othe