Senior Quality Engineer (Temporary to Potential FT Hire)

About the Team

The Quality and Regulatory team at Cleerly has the mission to empower team members to bring new, safe, and effective products to market and implement a quality foundation to support a patient-focused, innovative heart care organization.

About the Opportunity

The Senior Quality Engineer will be expected to contribute to maintaining the Quality Management System of Labs 2.0 with an emphasis in Complaints and CAPA’s.    

This is a Temporary position (3-4 months) with an opportunity to convert to full-time employment. The hourly rate will be $55-65 per hour, working full-time hours. 

Responsibilities

• Implements and maintains effectiveness of the Quality Management System.  This will include the responsibility for Quality documents including Standard Operating Procedures, Work Instructions and other records as required.
• Integrate Analysis activities regarding product improvements, audits, and new product development.
• Tracking, documenting, and coordinating activities within Quality that affect repeatability and reproducibility.
• Implement and remediate processes for complaints to ensure defendable compliance to 21CFR820, and MDSAP.
• Participate and lead Risk Analysis initiatives (Health Hazard Evaluations, Health Risk Assessments, Risk Management File updates)
• Remediate the Corrective Action Preventative Action process and system to ensure full defendable compliance to the 21CFR820 and MDSAP.
• Document processes and procedures as required
• Perform Internal Audits
• Support External Audits (FDA, MDSAP, ISO etc)
• Coordinates the interactions between Quality, Engineering, Product Support, and Regulatory to ensure appropriate processes and changes are created, reviewed, and documented.

Requirements

• BS in scientific discipline such as Biochemistry, Chemistry, Biology, or related discipline preferred. 
• Minimum 5 years of Quality Engineering experience in medical device, biotech, or pharmaceutical industry with bachelor’s degree. 
• Must have a good understanding of the US (FDA) federal regulations and medical device requirements outside of the US.
• Having startup experience is preferred
• Experience using quality management systems software (e.g. Agile/Veeva) preferred.
• Strong English Language skills are essential.
• Strong computer literacy required (e.g. MS Office Suite, etc.)
• Strong technical writing and communication skills
• Ability to apply Good Documentation Practice (GDP) requirements as they relate to quality management systems.
• Experience with process control, gauge R&R, and other Quality tools (5 Whys, Fishbone, CAPA processes, etc.)
• Familiarity with MDR and FDA level audits.
• Ability to work interdepartmentally effectively with good interpersonal skills.