Design Assurance Quality Engineer II - Medical Device

Overview

Description

Job Summary:

The Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization working with cross-functional development teams to establish and maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product to the customer.

• Adheres to Resolution Medical’s Core Beliefs and all safety and quality requirements
• Apply sound, systematic problem-solving methodologies to resolve quality issues
• Act as an effective team member in supporting quality disciplines, decisions, and practices
• Monitor field performance of recently launched and established medical devices against risk assessments
• Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization
• Support the verification, validation, and usability testing of changes to commercial designs to meet or exceed internal and external requirements
• Partner cross-functionally to identify and support value improvement efforts to support business goals
• Support post market surveillance of products through competent authority communication
• Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
• Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs
• 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 inquires
• Change Control - lead documentation change orders per quality system requirements
• Risk Management - use and interpret Hazard Analysis, use/update/create Failure Modes and Effects Analysis
• Foster/sustain "Voice of Quality" and "Quality 1st mindset"
• Recommend and make changes to QMS procedures, SOPs, Work Instructions and other related documents as necessary
• Performs other functions as required

Education, Experience,
and
Required
Skills

• BS Industrial Engineering, Engineering or Business Degree and 4-7 years of medical device experience in Quality Operations, or equivalent experience preferred
• FDA regulations, ISO 13485, ISO 14971

• Statistical and data analysis
• Supervisory, Solid Management and Strong Leadership experience

• Prolonged periods sitting at a desk and working on a computer.
• 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.

• Group health & welfare benefits:
  Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts.
• Company-paid benefits:
  Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Kavira (requires participation in medical plan).
• Voluntary, employee-paid benefits:
  Employee Supplemental Life & AD&D, Spouse and Dependent Life & AD&D, Short Term Disability (STD), Accident, Critical Illness, and Hospital Indemnity, Employee Assistance Program.
• Flexible Time Off Program
• Paid Parental Leave
• Paid Holidays
• Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.

• The typical base pay range for this role is between $85,/year. Compensation will vary based on individual job-related knowledge, skills, expertise, and experience. This position is eligible for a discretionary annual incentive program driven by organization and individual performance.
• 401(k) Plan:
  Company-provided Safe Harbor Contribution of 3% of eligible earnings.