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

Central Business Solutions•Tempe, AZ

8d•$110,000 - $115,000•Onsite

About The Position

We are seeking a Staff Quality Engineer with technical leadership skills and a deep understanding of medical device and pharmaceutical operations. This role involves leading quality engineering activities throughout the product development lifecycle, ensuring compliance with regulatory standards, and contributing to the successful launch of new products. The ideal candidate will have extensive experience in design controls, risk management, and validation activities within the medical device and pharmaceutical industries.

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 the 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.
8+ years experience in New Product Development of combination devices.

Responsibilities

Provide technical leadership in medical device and pharmaceutical operations, including manufacturing, process development, and quality assurance.
Create, support, review, and investigate analytical test methods for pharmaceutical combination devices.
Create, support, and review Chemistry, Manufacturing, and Controls (CMC) device submissions.
Lead the 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 the 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.
Serve as quality engineering representation on Product Development and Design Review teams.
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, and government regulations.
Actively participate in training and provide input to employee training on division procedures and policies.
Travel for business, project, and issues approximately up to 25% of time.
Perform other duties and projects as assigned.