Quality Engineer – Manufacturing

Job Description

Medica develops and manufactures affordable clinical analyzers and other products for the diagnostic laboratory and point-of-care settings. The company’s unique approach to design results in analyzers that are accurate, easy-to-use and maintain, and are ideally suited for the low volume in-vitro diagnostic testing market. Since its humble beginnings, Medica’s growth has been the result of its strategic focus on the worldwide need for accurate and reliable diagnostic tools that help lower healthcare costs.

The Quality engineering position is directly responsible for the continued maintenance and further development of the Quality Management System and quality improvement activities and opportunities as it relates to Manufacturing operations.

Key Responsibilities

• Oversee the Quality Assurance Manufacturing activities of medical devices and related chemistries. Investigate causes of quality and yield problems throughout the manufacturing processes. Ensure that quality and regulatory requirements are met for all products. O
• Oversee aspects of Quality Control, receiving inspection activities, and MRB.
• Oversee the CAPA, NCR and Investigation processes.
• Initiate corrective and preventive action and quality improvement activities.
• Evaluate quality data including investigating complaints, nonconformances, and CAPAs. Drive for root cause understanding and corrective action implementation.
• Perform or assist with the quality system internal auditing process. Contribute to timely closure of audit findings.
• Support management review meetings. Establish, monitor, and evaluate KPIs.
• Author, review and / or approve QMS procedures and documentation; Deviations, Ship Stops, Technical Service Bulletins, Verification and Validation Protocols, and other documentation as required.
• Supports the successful transfer of products to manufacturing by ensuring the adequacy of process validation, design transfer plans, quality plans and supplier documentation.
• Participate in Risk Management process, including the development and maintenance of risk management files, ensuring compliance with ISO 14971.

Qualifications

• BS in Chemistry, Biomedical, Electrical, Mechanical, or Industrial Engineering is required.
• Minimum of 5 years Quality/Engineering experience.
• Direct FDA GMP and ISO 13845 Quality System experience.
• Applied knowledge of quality and statistical tools such as Six Sigma, Lean Manufacturing, 5S, SPC, engineering studies, DOE, Gauge R&R.
• Applied knowledge of FDA and international medical device regulations.
• Exceptional computer skills – Word, Excel, Power Point, Access, or other database programs
• Strong organizational, attention to detail and follow-through skills
• Demonstrated problem-solving and troubleshooting skills
• Excellent writing and verbal communication skills

Preferred Qualifications

• Detailed understanding of FDA 21 CFR 820, ISO 13485, MDSAP, and EU IVDR, CMDR requirements.
• ASQ CQE/CSQE/CQA, RAPS, or equivalent QA/RA certification preferred.
• Flexibility to support changing assignments and priorities in an independent and reliable manner while maintaining a positive and collaborative demeanor.
• Sophisticated analytical and problem-solving skills.

Interested Applicants should forward their resume to:

Mary Williams
Human Resources Manager
Medica Corporation
[email protected]