Quality Engineer

Position Overview:

The Quality Engineer will provide hands-on Quality Assurance and Quality Systems support for LifeSprout’s medical-device development, manufacturing, and related operations at the Baltimore facility.

The Quality Engineer will support the maintenance and effective execution of the Quality Management System and help ensure that products, processes, facilities, equipment, materials, and associated records comply with applicable internal procedures and regulatory requirements. The role requires close collaboration with Quality Assurance, Regulatory Affairs, Research and Development, Manufacturing, Operations, Supply Chain, and external suppliers.

The position will support activities involving design and development quality, manufacturing quality, deviations and nonconformances, corrective and preventive actions, change control, supplier quality, document control, validation and qualification, batch documentation, product and material release, and audit readiness. The individual must be comfortable working onsite in a fast-paced environment, managing multiple priorities, and completing time-sensitive quality deliverables.

Responsibilities:

• Provide hands-on Quality Assurance support for manufacturing, engineering, development, and QMS activities.
• Support deviations, nonconformances, CAPAs, change controls, document control, training, and supplier quality activities.
• Review and approve controlled documents, batch records, protocols, validation/qualification documentation, investigations, and reports within assigned authority.
• Support material and product disposition, release activities, and management of nonconforming materials.
• Support process validation, equipment qualification, design controls, and risk management activities.
• Support supplier qualification, supplier corrective actions, supplier audits, and performance monitoring.
• Participate in internal/external audits and regulatory inspections and support timely closure of findings.
• Partner with R&D, Manufacturing, Operations, Regulatory Affairs, and Supply Chain to resolve quality issues and maintain regulatory compliance.
• Provide Quality guidance and oversight while working with appropriate technical subject-matter experts on technical decisions.
• Perform other Quality Assurance/Quality Engineering activities as needed to support business continuity during the temporary assignment.

Qualifications:

• Bachelor’s degree in engineering, Life Sciences, or another relevant scientific or technical discipline.
• At least five years of Quality Assurance or Quality Engineering experience in medical devices, combination products, biologics, pharmaceuticals, or another regulated life-sciences industry.
• Hands-on experience with ISO 13485 and FDA medical-device Quality System requirements.
• Working knowledge of core QMS processes, including CAPA, deviations, nonconformances, change control, document control, training, audits, and supplier quality.
• Experience reviewing or supporting validation protocols, qualification documentation, investigations, technical reports, or manufacturing records.
• Demonstrated ability to independently manage assigned deliverables and milestones.
• Strong technical writing, documentation-review, communication, organization, and problem-solving skills.
• Ability to work onsite at the Baltimore facility and manage shifting priorities in a fast-paced environment.
• Eligibility to work in the United States.

Preferred Qualifications:

• Experience with EU MDR, ISO 14971, FDA QMSR, or other applicable international medical-device requirements.
• Experience supporting design controls, risk management, process validation, equipment qualification, or technology transfer.
• Experience conducting investigations and supporting risk-based product, material, equipment, or facility disposition.
• Experience supporting regulatory, notified-body, certification-body, or supplier audits.
• Experience reviewing batch records and supporting material or product release.
• Experience with complaint handling, post-market surveillance, supplier quality, or technical-file documentation.
• ASQ Certified Quality Engineer, Certified Quality Auditor, or comparable qualification is desirable but not required.

Temporary Assignment Expectations:

The successful candidate must be able to become effective quickly, work from established procedures, and independently manage assigned quality deliverables. Initial priorities may include open or ongoing deviations, nonconformances, CAPAs, change controls, supplier-quality actions, validation or qualification records, manufacturing documentation, document revisions, and audit-readiness activities.

The position does not include formal responsibility for supervising or evaluating Quality Assurance personnel.