Sr. Manager, Quality Engineering ADD

Essential Duties and Responsibilities

• Provides strategy and leadership over the Quality Engineering (QE) teams at both Rockford Linden sites.
• Serves as subject matter expert (SME) and process owner for the Design Control and Risk Management procedures within the Quality Management System.
• Oversees and approves PCI investigations including calibration OOS and laboratory or environmental monitoring product impact investigations.
• Oversees and approves site supplier nonconformances and supplier related quality metrics.
• Processes owner for Measurement System Analysis (MSA), Control Plans, Process Flow Maps, Inspection plans and techniques, GR&R, test requirements and Test Method Transfer/Validation.
• Oversees and provides input for statistical assessment of data to drive improvements.
• Supports and maintains quality assurance programs and systems, policies, processes, procedures and controls.
• Prepares reports to company management detailing the status of open projects.
• Participates in regulatory inspections, customer audits, visits and conference calls.
• Supports the recruitment, coaching, and development of Quality Engineers.

Qualifications

• Required: College or Trade Degree in engineering or related scientific field.
• Minimum of 5+ years of experience in an FDA regulated industry, with strong preference to medical device or combination products.
• Proficiency with personal computers, business software (e.g., MS Office) and technical software (ERP and eQMS systems).
• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Analytical ability to drive effective Root Cause Analysis (RCA) and critical thinking for complex problem solving.

Benefits

• Paid time off
• Health insurance coverage (including dental and vision)
• A flexible spending account
• A 401(k) plan