One of our medical device clients is looking to add a Quality Engineering Program Manager to their team in Tempe, AZ. This position is part of the Quality Engineering Team whose responsibility is to support new product development and sustaining for combination drug products. This individual will be managing a team of about 5 people so ideally our client is looking for someone who has experience in a people management role. This individual should have a strong background in quality R&D as well as combo/drug product experience. This person can definitely come from a quality manager role if they've done relevant projects/activities. Essential/Key Job Functions:
- Performs supervisory responsibilities for direct reports, including but not limited to, performance reviews,
- recommending salaries and promotions, training, interviewing, and hiring decisions and disciplinary actions.
- Identifies development needs and potentials of employees, and provides or recommends project assignments and training to increase expertise to meet current or future division needs.
- Provides technical support and feedback for direct reports.
- Participates as team leader or as an active member of the team to meet company objectives and ensure department responsibilities are completed.
- Actively participates in training and providing input to training of employees on division procedures and policies.
- Develop and implement procedures to comply with corporate and industry standards.
- Assesses priorities and makes assignments to direct reports to ensure project and company priorities are met.
- Coordinates and/or directs all aspects of product development activity related to a product line.
- Leads development of risk assessments and test methods
- Leads and/or support product investigations
- Ability to make and present risked based decisions
- Quality engineering representation on Product Development Teams 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.
- Complies with company procedures and policies, government regulations.
- Knows how products are used and impact the user(s) so that risk can be managed effectively.
- Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc…)
- 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
- Ability to create and provide training\
- Problem solving ability
- Ability to generate engineering proposals
- Oral and written presentation skills
- Ability to Lead cross functional teams
- Understanding of regulatory requirements including 21 CFR 210, 211, ICH Guidelines, ISO 13485, ISO 14971
- Ability to lead creation of risk management files
- BS Engineering
- Minimum of eight years experience in (Master's degree plus five years) engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry.
- Minimum of three years experience in supervisory capacity.
- Quality Engineering Certification (ASQ) or equivalent