Staff Quality Engineer - Product Development, Tempe, AZ - (IK)

Central Business Solutions•Tempe, AZ

23d•$110,000 - $115,000•Onsite

About The Position

The Staff Quality Engineer - Product Development will provide technical leadership in the area of medical device and pharmaceutical operations. This role involves creating, supporting, reviewing, and investigating analytical test methods, as well as contributing to chemistry, manufacturing, and controls (CMC) device submissions. The engineer will lead the development of risk assessments and test method activities, including development and validation. They will also lead component qualifications, design validation, design verification, drug stability, and process validation. Product investigations will be a key responsibility, requiring the ability to make and present risk-based decisions. The role supports the translation of design inputs into manufacturing control plans and involves developing and implementing procedures to comply with corporate and industry standards. The Staff Quality Engineer will coordinate product development activities for a product line, represent Quality Engineering on Product Development and Design Review teams, and prepare project updates. They will participate in project planning, budgeting, scheduling, and tracking, and support internal and external supplier audits. Additionally, this role provides support to the regulatory department for technical submissions and ensures compliance with company policies and government regulations. Active participation in training and policy development is expected. The position requires the ability to travel up to 25% of the time.

Requirements

BS in Engineering, Biological Science, or a related engineering field (Masters or Ph.D preferred). Fields of study include Chemical Engineering, Bioengineering, Pharmacy, or Biochemistry.
Minimum of eight years of experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry.
Extensive proven understanding of design controls in development stage.
Pharmaceutical or combination product experience.
Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.).
Ability to lead creation of risk management files.
Ability to develop solutions with business impact.
Advanced statistical and risk assessment techniques.
Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies.
Ability to make and present risk-based decisions.
Strong interpersonal skills.
Ability to analyze and optimize manufacturing and quality systems.
Product, design & prototyping.
Ability to create and provide training.
Problem solving ability.
Ability to create, review and coordinate test protocols and reports.
Ability to generate engineering proposals.
Oral and written presentation skills.
Ability to lead cross functional teams.
Understanding of regulatory requirements including ISO 13485, ISO 14971, 21 CFR 210/211/820, ICH Guidelines.

Nice To Haves

Masters or Ph.D preferred.
Ideal Candidate 8+ years experience in New Product Development of combination devices.

Responsibilities

Provide technical leadership in medical device and pharmaceutical operations.
Create, support, review, and investigate analytical test methods for pharmaceutical combination devices.
Create, support, review chemistry, manufacturing, and controls device submissions.
Lead development of risk assessments and test method activities (e.g., development and validation for physical and analytical test methods).
Lead component qualifications, design validation, design verification, drug stability, and process validation.
Lead product investigations.
Make and present risk-based decisions.
Assess product changes against product design.
Support translation of design inputs into manufacturing control plans.
Develop and implement procedures to comply with corporate and industry standards.
Coordinate and/or direct all aspects of product development activity related to a product line.
Prepare and present project updates and technical discussions.
Participate in project planning, budgeting, scheduling, and tracking.
Support internal and external supplier audits.
Provide support to the regulatory department in writing technical submissions.
Comply with company procedures and policies, government regulations.
Actively participate in training and providing input to training of employees on division procedures and policies.
Travel for business, project, and issues approximately up to 25% of time.
Perform other duties and projects, as assigned.