Job Description

This is a remote position.

We are seeking a talented and self-driven Quality Engineer to ensure all products, processes, and quality systems within the organization comply with applicable medical device regulations and global standards. This role is integral to driving quality excellence across the product lifecycle from design and development through manufacturing, validation, and post-market support.
The ideal candidate possesses a strong technical foundation, meticulous attention to detail, and a proactive approach to problem-solving and continuous improvement. This individual will collaborate cross-functionally with R&D, Manufacturing, Regulatory, and Supplier Quality teams to uphold the highest levels of product safety, compliance, and performance.
Key Responsibilities
Support design control activities, ensuring design inputs, outputs, verification, and validation meet regulatory and organizational requirements.
Participate in risk management activities (ISO 14971), including FMEA and hazard analysis.
Review and maintain Design History Files (DHF), technical documentation, and change control records.
Collaborate with R&D, Manufacturing, and Regulatory teams to ensure compliant design transfer into production.
Support and lead process validation activities (IQ/OQ/PQ), ensuring adherence to validation master plans.
Evaluate nonconformances and conduct root cause investigations using structured problem-solving tools (5 Whys, Fishbone, etc.).
Drive Corrective and Preventive Actions (CAPA) to timely closure and verify effectiveness.
Monitor production processes and quality metrics, identifying trends and improvement opportunities.
Support equipment qualification, calibration, and validation maintenance to ensure compliance.
Participate in supplier qualification, performance monitoring, and audits to verify compliance with quality requirements.
Manage Supplier Corrective Action Requests (SCARs) and collaborate with suppliers to resolve quality issues.
Review incoming inspection results, PPAP documentation, and supplier process records.
Maintain and continuously improve the Quality Management System (QMS) in compliance with 21 CFR Part 820, ISO 13485, MDSAP, and EU MDR.
Prepare for and support internal, external, and regulatory audits, including documentation and response management.
Create, revise, and implement Standard Operating Procedures (SOPs) and work instructions.
Participate in change control reviews to ensure ongoing product and process compliance.
Utilize data analysis and statistical tools (SPC, Cpk, Minitab, etc.) to drive process and product improvements.
Apply Lean Six Sigma methodologies to enhance efficiency and reduce waste.
Contribute to cross-functional projects focused on risk mitigation and operational excellence.
Support training and mentoring of cross-functional teams on quality principles, tools, and regulatory expectations.
Must-Have Qualifications
Bachelor’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, or a related scientific discipline.
Experience in a regulated medical device environment with working knowledge of FDA QSR, ISO 13485, and ISO 14971.
Hands-on experience in process validation, CAPA, risk management, nonconformance investigations, and audit support.
Familiarity with statistical analysis tools and data-driven quality decision-making.
Strong communication, documentation, and cross-functional collaboration skills.
Certification in Lean Six Sigma, ASQ CQE, or a similar credential preferred.
Preferred Qualifications
Working knowledge of MDSAP, EU MDR, and other international regulatory frameworks.
Proficiency with electronic QMS platforms (e.g., MasterControl, TrackWise, Veeva).
Experience with combination products, sterilization validation, or cleanroom manufacturing environments.
This is intended for inclusion in Pharmavise’s talent database to build a qualified pool of professionals for future medical device client requisitions.

About Pharmavise Corporation

♦𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐮𝐚𝐥𝐢𝐭𝐲♦: 𝐏𝐡𝐚𝐫𝐦𝐚𝐯𝐢𝐬𝐞, 𝐲𝐨𝐮𝐫 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬, 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐚𝐧𝐝 𝐆𝐨𝐯𝐞𝐫𝐧𝐦𝐞𝐧𝐭 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐩𝐚𝐫𝐭𝐧𝐞𝐫.

𝗔𝗯𝗼𝘂𝘁 𝘂𝘀 𝗜𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻:

We provide high-quality, cost-effective people and process solutions for your Quality, Regulatory, Engineering, Clinical, and Healthcare needs. Our company mantra 𝐄𝐗𝐂𝐄𝐋𝐋𝐄𝐍𝐂𝐄 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐔𝐀𝐋𝐈𝐓𝐘. The safety and quality of the drugs and devices produced for patients are directly related to 2 things, 𝐑𝐎𝐁𝐔𝐒𝐓 𝐏𝐑𝐎𝐂𝐄𝐒𝐒 𝐚𝐧𝐝 𝐐𝐔𝐀𝐋𝐈𝐅𝐈𝐄𝐃 𝐏𝐄𝐎𝐏𝐋𝐄. 𝐖𝐞 𝐝𝐞𝐥𝐢𝐯𝐞𝐫 𝐛𝐨𝐭𝐡.

𝐃𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐭𝐢𝐚𝐭𝐨𝐫𝐬:

☑𝐇𝐢𝐠𝐡𝐥𝐲 𝐒𝐤𝐢𝐥𝐥𝐞𝐝 𝐓𝐞𝐚𝐦: Our team of experienced consultants with distinct backgrounds in life sciences, including scientists, researchers, and regulatory experts. The quality and expertise of our team significantly impact our client’s success.

☑𝐒𝐩𝐞𝐜𝐢𝐚𝐥𝐢𝐳𝐞𝐝 𝐄𝐱𝐩𝐞𝐫𝐭𝐢𝐬𝐞: We focus on specific niches within the life sciences, healthcare, and government sectors, such as pharmaceuticals, biotechnology, medical devices, regulatory affairs, medical research, and product development. This specialized expertise allows us to offer targeted and in-depth insights to our clients.

☑𝐂𝐮𝐬𝐭𝐨𝐦𝐢𝐳𝐞𝐝 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬: We offer tailored solutions that align with the specific requirements of each client, rather than one-size-fits-all approaches, demonstrating a commitment to meeting client needs. We do not require a long learning curve, which leads to a faster payback and a greater return on your investment.

𝗣𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗛𝗶𝘀𝘁𝗼𝗿𝘆

Over 20 Technical Transfers and 30 product launches.

11 FDA remediations. Warning Letters and or Consent Decrees.

Cost savings and increased efficiency of over 10MM for clients

Industry

Consulting & Advisory

Company Size

11-50 employees

Headquarters

Fort Lauderdale, Florida

Year Founded

2013

Website

pharmavise.com

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