Contract Capa Engineer Jobs Near Me

EWI is the leader in materials sciences and the go to experts that many of the country's largest and most innovative organizations call to assist with their most difficult assignments. Our business success relies on strong execution and continuous improvement - driven by the expertise and teamwork of our employees. We are always searching for exceptional candidates to join the EWI team and be a part of our forward-thinking, innovative, best-in-class organization! We have a rich history in the community and are and are proud to call Columbus our home.
We are seeking a highly experienced and strategic Senior Quality Manager to build and lead our quality function from the ground up. This is a senior leadership role responsible for establishing a robust Quality Management System (QMS) and driving a culture of quality, compliance, and continuous improvement across the organization. The ideal candidate brings deep expertise in regulated environments and a strong background in contract research.
ESSENTIAL FUNCTIONS:

• Establish and lead the QMS: Design, implement, and institutionalize a comprehensive Quality Management System from the ground up, ensuring alignment with relevant regulatory standards and business objectives
• Define and own all quality policies, procedures, work instructions, and standards across manufacturing and engineering operations
• Serve as the organization's senior quality authority, providing strategic direction and guidance to executive leadership on all quality-related matters
• Lead all internal and external audits, including regulatory inspections, and ensure timely and effective resolution of findings
• Oversee root cause analysis (RCA) and corrective/preventive action (CAPA) processes across the organization
• Build, mentor, and scale a high-performing quality team, including quality engineers, auditors, and inspectors
• Partner with contract research organizations (CROs) and external partners to ensure quality standards are met throughout outsourced activities
• Manage supplier and vendor quality programs, including qualification, audits, and ongoing performance oversight
• Drive continuous improvement initiatives using methodologies such as Lean, Six Sigma, or 8D
• Represent the quality function in client-facing interactions, regulatory submissions, and contract negotiations
• Monitor and report on quality KPIs, trends, and risks to the executive team and board as required

KNOWLEDGE/SKILLS/ABILITIES:

• Demonstrated experience establishing a QMS from inception in a regulated industry
• Strong knowledge of quality standards and frameworks (ISO 9001, ICH Q10, GxP, FDA 21 CFR, ISO 13485, AS9100 or equivalent)
• Proven experience working within or managing contract research environments, including oversight of CROs and third-party partners
• Deep expertise in audit management, CAPA, risk management, and regulatory compliance
• Exceptional leadership, communication, and stakeholder management skills
• Ability to operate effectively at both the strategic and operational level
• Familiarity with ITAR/EAR compliance requirements
• Prior experience interfacing directly with regulatory bodies
• Proficient in MS Office products (Word, Excel, PowerPoint, etc.)
• Excellent verbal and written communication and interpersonal skills
• Ability to work well with ever-changing priorities and/or situations
• Exhibit and maintain positive, solutions-oriented attitude toward work and co-workers
• Excellent organizational skills and ability to work well under stress, despite numerous interruptions
• High degree of accuracy and attention to detail in assigned tasks on a consistent basis
• Outstanding interpersonal skills and ability to communicate effectively with all levels of associates
• Team-oriented attitude and focus with strong ability to collaborate with others

PREFERRED QUALIFICATIONS:

• ASQ Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or equivalent
• Six Sigma Black Belt or Master Black Belt certification
• NADCAP accreditation experience in one or more special processes (e.g., NDT, welding, heat treating, chemical processing)
• Familiarity with electronic QMS (eQMS) platforms and data integrity requirements

EDUCATION:

• B.S. in Engineering or a related field
• Master's degree or MBA preferred

EXPERIENCE:

• Ten (10) or more years of progressive quality management experience
• Three (3) years in a senior or director-level role
• Experience with government contracts
• Experience in a manufacturing or contract research environment is desirable

EXPORT CONTROLS - This position requires access to information and technology that is subject to U.S. export controls. To conform to U.S. export control regulations, applicant should be eligible for any required authorizations from the U.S. Government.
EOE/M/F/Disability/Protected Veteran Status
Accommodation:
Individuals who need reasonable accommodations under the ADA in order to participate in the search and/or application process should contact Human Resources at (614) 688-5000.