Senior Design Quality Engineer I
Role details
Job location
Tech stack
Job description
Purpose: This person will have the opportunity to perform various Design Quality Engineering functions supporting continuous improvement and innovation of marketed products! Activities will include risk management, design verification, design validation, design assurance activities, as well as manufacturing process development support statistical analysis and more! This role's emphasis will be in support of Abiomed's existing single-use heart pumps.
You will be responsible for:
- Support and lead Design Assurance engineering activities in support of Abiomed's Life Cycle processes including design controls, quality planning, risk assessments/analysis/management, design reviews, test method development and validation, design and process verification and validation test plans and reports, post-market monitoring, investigations, follow-up and reporting.
- Expertly navigate existing FMEA's and Hazard Analysis in support of sustaining and lifecycle activities.
- Ensure that FDA and other regulatory knowledge and experience is applied to risk and testing assessments.
- Work with manufacturing engineering to ensure necessary process controls are in place for design changes.
- Review and approve Engineering Change Requests (CR's) and support the Non-Conformance (NC's) process as necessary.
- Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA, etc), ISO 13485, MDD, CMDR, CMDCAS and other national and international quality and regulatory requirements and standard.
- Contribute to the design, development and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance.
- Collect, analyze & report on quality system metrics: CAPA, complaint trends, manufacturing trends, etc.
- Develop statistically sound sampling plans and perform data analysis.
- Participate in design reviews for the system as well as review and approve design input/design requirements, design documents, test results, verification and validation.
- Be a voice of quality and ensure compliance to internal & external quality standards.
- Bring ideas that challenges curent thinking.
- Serve as a 'go-to' for quality & multi-functional team members.
- Independent decision maker, provides strategic solutions to multi-functional team with minimal guidance from leadership.
- Mentor Newer QE's on business practices and quality tasks.
Requirements
- Bachelor degree in Engineering or Sciences is required.
- Minimum of 8 years of quality experience.
- Experience in the medical device industry highly preferred.
- Demonstrates solid understanding of quality engineering policies, principles standards and FDA/ISO requirements.
- Takes initiative and demonstrates leadership and team work., Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)
Benefits & conditions
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
