Job Type

Full-time
Description
Job Summary:
The Sr Quality Engineer is responsible for overseeing and supporting the quality control and assurance systems of the operations for transfers and existing manufacturing, conducting quality audits, developing and implementing quality control procedures and policies, analyzing and resolving quality-related issues and ensuring compliance with regulatory requirements. Provides expertise in the design, development, transfer and implementation of suitable quality controls for new or existing products & processes. Develop and implement product quality plans, documents, and systems by creating product specifications, quality specifications, project quality plans, risk analysis, FMEAs in conjunction with other product development and manufacturing team members
Essential Functions:

• Adheres to Resolution Medical's Core Beliefs and all safety and quality requirements
• Non-Conforming Material Reports (NCMR) including root cause investigation, risk assessment, historical record review, disposition strategy, correction activities.
• Complaints Reviews/Manufacturing Analysis including event assessment, root cause investigation, risk assessment, historical record review, impact/action escalation.
• Corrective Action Preventive (CAPA); including root cause investigation, scoping/bracketing, resolution planning, implementation, and verification of effectiveness.
• Regulatory requests including certification of compliance and product inquiries.
• Manufacturing/Production Line Support - partnering with operations team members to achieve value stream goals and objectives.
• Change Control - lead documentation change orders per quality system requirements.
• Validation/Qualification - Lead/review Installation Qualification, Process Qualification, Operational Qualification, Product Performance Qualification (PPQ), Master Validation Plan/Report, and Test/Inspection Method Validation.
• Deviations - including risk assessment, closure criteria
• Risk Management - use and interpret Hazard Analysis, use/update/create Failure Modes and Effects Analysis.
• Foster/sustain "Voice of Quality" and "Quality 1st mindset".
• Support backroom during audits.
• Line Reviews - supports timely completion of manufacturing front line personnel reviews.
• Provide leadership and support to 2-3 direct reports for their professional and personal development
• Provide work direction and support to 2-3 direct reports for their professional and personal development
• Recommend and make changes to QMS procedures, SOPs, Work Instructions and other related documents as necessary
• Performs other functions as required

Requirements
Education, Experience, and Required Skills:

• Bachelor's in Industrial Engineering, Engineering or Business or 15 years of experience in Quality Operations in a medical device company.
• 5 years Quality experience in medical device manufacturing or related industry
• Thorough knowledge of and experience with FDA regulations, ISO 13485, ISO 14971, CAPA, Complaint/MDR

Preferred Skills:

• Statistical and data analysis
• Team leadership experience (formal or informal)

Physical Requirements:

• Prolonged periods sitting at a desk and working on a computer.
• Ability to sit, stand, lift, bend and stoop numerous times throughout the day.
• Must be able to lift 25 pounds at times.
• Must have manual dexterity.
• Must have excellent hand-eye coordination.
• Must wear gown, gloves, and ear protection if applicable.