Fresh Consulting is a design-led, software development and hardware engineering company, offering end-to-end services to help companies innovate. We bring together amazing UX designers, sophisticated developers, digital strategists, and top-notch engineers to help companies create fresh experiences that connect humans, systems, and machines.
At Fresh Consulting, we strive to hire a workforce representative of the communities we serve, understanding that a diverse workforce strengthens our organization. We value diversity and support a positive and welcoming environment where all of our employees can thrive. See more at freshconsulting.com
We are looking for a Quality Manager to plan, develop, implement and manage a Quality Management System (QMS) that satisfies requirements for the ISO 9001:2015 standard and all regulatory/legal requirements. They will be responsible for leading the organization through the entire ISO 9001 transition process. Experience with additional regulations and regulatory environments, including IITAR, HIPPA, ISO 13485, FCC, CE, Safety regulation for manufacturing or automation, would be a benefit for assisting with various client needs during the course of the diverse programs we serve.
- Implementing and governing a QMS that is compliant with ISO 9001:2015 regulations.
- Leading teams in assuring quality of product and customer service
- Determining root cause of quality issues and proposing solutions
- Training employees on QMS related items
- Qualifying vendors and monitoring their performance
- Reporting performance of QMS to leadership team using key metrics (i.e. supplier performance, audits corrective actions, improvement efforts, etc.)
- Creating, reviewing and/or approving Control Plans and Process FMEA’s
The candidate will possess these skills:
- 5-10 years of Quality Management and ISO 9001 or similar experience
- Previous experience in leading or participating in ISO 9001 implementation.
- Process and product auditing
- Ability to form trusting relationships with internal and external customers.
Experience that would be a plus:
- A solid understanding of statistical data analysis and problem-solving processes.
- Experience in Medical Device Development
- Experience with Quality systems in a consulting environment
- Experience with implementation and oversight of safety standards
- Experience with implementation of training programs
The candidate will possess these attributes:
- Ability to effectively lead without authority throughout all departments.
- Strong business acumen
- Strong leadership skills
- High integrity
- A passion for success
Education & Certifications:
- Degree in science, quality, manufacturing or engineering
- Lean certification preferred.
Equal employment opportunity: All qualified persons will be considered for employment without regard to race, color, religion, sex, national origin, age, marital status, familial status, gender identity, sexual orientation, disability for which a reasonable accommodation can be made, or any other status protected by law. Assistance will be gladly provided upon request for any applicant with sensory or non-sensory disabilities.
*Fresh Consulting is an E-Verify participating company.