Quality Assurance Manager

Cypress HCM; Gaithersburg (MD); On-site; USD 120,000 - 150,000; Full time

Job summary

A medical device client is seeking a Quality Manager in Gaithersburg, MD. The role involves overseeing quality strategy, ensuring compliance with FDA and ISO regulations, and leading a quality team. The ideal candidate should have extensive experience in quality management within the medical device industry.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• 3 to 5 years of experience in a quality management role.
• Extensive quality experience in FDA and ISO regulated environments.

Responsibilities

• Oversee Quality strategy and ensure compliance with regulatory requirements.
• Lead the Quality team and collaborate with Operations, R&D, and Regulatory.

Skills

Quality Management

Regulatory Compliance

Process Improvement

Education

BS in a scientific discipline

Tools

HPLC

MS

GCMS

UV-Vis

NMR

Job description

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Direct message the job poster from Cypress HCM

A medical device client is looking to hire a Quality Manager onsite in Gaithersburg, MD. This position will be responsible for planning, organizing, and overseeing Quality strategy to ensure the timely delivery of safe and effective products that meet all regulatory and compliance requirements. This role will partner with the head of quality to make sure that processes required for the Quality Management System(s) are effectively established, implemented, maintained, and will proactively develop improved processes to comply with the requirements of 21 CFR Parts 820 1271. This person will help lead the Quality team and work closely with the key partners, including Operations, R&D and Regulatory.

Experience Needed:

• BS in a scientific discipline required.
• 3 to 5 years of experience in a quality management role
• Extensive quality experience in a FDA and ISO regulated environment, with specific knowledge of 21 CFR Part(s) 820 and 1271.
• Significant experience in the medical device and pharmaceutical industries in both Commercial and R&D/Product development environments
• Experience with combination products (device/ drug) a plus
• Demonstrated capability in business process/system management and improvement
• Experience interfacing with government and accreditation agencies (FDA, ISO, AATB), managing audits and supporting regulatory filings, responses and other documents required in a regulated environment.
• Experience with analytical drug testing (HPLC, MS, GCMS, UV-Vis, NMR, etc.), interpreting results, and troubleshooting as needed.
• Understand company strategy, anticipate quality requirements, and implement changes or improvements to support business growth
• Manage/oversee Quality Assurance responsibilities related to Operations, Quality Systems and Quality Engineering activities.
• Help the Quality Leader manage the quality org by building out a team for the Gaithersburg, MD facility
• Establish and implement the quality systems to comply with regulatory requirements, including FDA QSR (21 CFR 820 and 1271), ISO 13485, CMDCAS, etc. as applicable to Elutia business requirements.
• Establish capabilities as needed to ensure quality standards are met and compliance requirements are consistently achieved throughout organization.
• Communicate status of the quality system to senior leadership using established metrics and reports.
• Lead or participate on multidisciplinary teams for new product development and/or to resolve complex product investigations.
• Manage, interact, and engage with FDA, notified bodies, and international regulators during on-site audits / inspections, field actions, recalls, or post market surveillance/vigilance activities.
• Engage with key external partners (e.g., vendors and consultants) on Quality priorities, process improvements, validations, etc.

Salary of $120-150K + bonus and benefits

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance and Management

• Industries

  Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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