The QA and QC Specialist at Medennium supports quality assurance and quality control activities throughout the product manufacturing process. This role involves performing inspections, measurements, and tests to ensure products meet internal specifications and regulatory requirements such as 21 CFR 820 and ISO 13485. The QA and QC Specialist will also be responsible for managing non-conformances reports, maintaining quality records, and supporting internal and external audits. The position requires a solid understanding of quality management principles, attention to detail, and the ability to work effectively as part of a cross-functional team.

RESPONSIBILITIES:

  • Quality Oversight: Lead and support quality control activities related to daily manufacturing, ensuring adherence to quality standards.
  •  Inspection Management: Oversee the inspection of product returns, incoming materials, and final products, ensuring compliance with specifications and regulatory standards.
  • Non-Conformance Management: Generate and manage Non-Conformance Reports (NCRs) for non-conforming materials and assemblies, and ensure appropriate actions are taken.
  • Labeling and Documentation: Perform and verify label and IFU inspections, and ensure manufacturing-related paperwork is accurate and complete.
  • Data Management: Document inspection results, maintain quality databases, and conduct trending analysis to monitor and improve quality metrics.
  • Controlled Environments and Final Release: Monitor and test-controlled room environments to ensure compliance with quality standards and perform final review and release of finished goods for distribution.
  • Process Improvement: Assist in updating QC procedures and specifications, and work to optimize efficiencies within the QC process.
  • Audit Support: Provide support during internal and external audits, ensuring all quality processes are compliant with applicable regulations.
  • Training and Mentorship: Train and mentor junior QA and QC staff, ensuring they are knowledgeable about quality standards and procedures.
  • Cross-Functional Collaboration: Work closely with other departments, including Supply Chain, Manufacturing, Operations, Regulatory Affairs, and Engineering, to ensure quality standards are maintained throughout the production process.
  • Problem-Solving: Identify, analyze, and resolve quality issues, using effective judgment and decision-making skills.
  • Continuous Improvement: Continuously seek opportunities to enhance quality control processes and contribute to a culture of quality within the organization.

QUALIFICATIONS:

  • Education: Associate degree in Science or Engineering preferred; relevant experience may substitute for formal education.
  • Experience: Minimum of 2 years of experience in QA/QC. Experience in medical device manufacturing is highly preferred.
  • Technical Skills: Proficient in Microsoft Office, especially Word and Excel. Experience with electronic Quality Management Systems (eQMS), preferably ETQ.
  • Regulatory Knowledge: In-depth knowledge of US FDA regulations, ISO 13485:2016, EU MDD, EU MDR, and other country-specific medical device regulations.
  • Analytical Skills: Strong analytical problem-solving skills with the ability to conduct investigations, analyze complex documents, and manage multiple tasks within tight timelines.
  • Communication Skills: Excellent verbal and written communication skills, with the ability to interact effectively with internal customers and present information clearly.
  • Leadership: Proven leadership skills with the ability to train, mentor, and guide junior staff members.
  • Attention to Detail: Strong attention to detail and a commitment to maintaining high standards of quality and safety.
  • Organizational Skills: Strong time management and organizational skills in a dynamic, fast-paced environment.
  • Interpersonal Skills: Ability to work effectively and establish constructive working relationships with staff across all departments.

PHYSICAL DEMANDS:

  • Manual Dexterity: Ability to operate machinery and equipment, including precision tools.
  • Standing and Walking: Frequently required to stand, walk, and move around the production floor for extended periods.
  • Lifting: Ability to lift and carry up to 30 pounds as needed.
  • Vision: Ability to see details at close range and perform precise measurements and inspections.