Job Description
Job Description
POSITION: Supplier Engineer
FULLTIME: 12-month assignment (Possible temp to perm)
LOCATION: Maple Grove, MN
SCHEDULE: Hybrid In office - Tuesday, Wednesday Thursday
PAY RANGE: $50/HR
(Exact compensation may vary based on skills, experience, and location. Base pay information is based on market location.)
JOB DESCRIPTION:
This project addresses a CAPA related to requirement to properly link design risks and design outputs to manufacturing processes performed by external suppliers. In this role, the Supplier Engineer will work closely with the design team to identify the key design outputs that are critical from a design-intent perspective, then collaborate with Sustaining Supplier Engineering (SE) and Quality Engineering (QE) to gather existing process validation documentation from suppliers. The team will review these validation packages against criteria developed from the design output list to determine whether each supplier meets minimum requirements. When gaps are identified, the engineer will partner with both the supplier and sustaining teams to remediate deficiencies, improve validation or documentation, and ensure alignment with expectations. This evaluation and remediation cycle will be repeated across all applicable contract manufacturers until all required supplier processes have been fully addressed.
About the role: This Supplier Engineer (SE) will be responsible for the remediation activities identified by CAPA 7720 for contract manufactured (CM) sourced finished medical device (SFMD) product. This individual works independently, serves as a leader for SE remediation activities, and interacts cross-functionally with team members and CM SFMD suppliers to execute deliverables according to business needs.
Responsibilities Include:
- Review, remediate, and approve CM SFMD supplier's process risk documentation (PFMEA) to newly defined criteria.
- Review, remediate, and approve CM SFMD supplier's process and inspection validations to statistical requirements.
- Perform change management activities to remediate gaps found in CM SFMD Supplier's process risk documentation and process/inspection validations.
- Collaborate with CM SFMD suppliers and functional resources to complete all activities needed to approve supplier's process risk documentation and process/inspection validations to the newly defined criteria.
- In all actions, it demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
What We're Looking For:
Required Qualifications:
- Bachelor's degree in engineering
- 1 – 2 years of experience in a manufacturing environment.
- Experience with installation qualifications (IQ), operational qualifications (OQ), performance qualification (PQ), and test method validation (TMV).
- Ability to travel up to 15% of the time (mostly domestic, could be international).
Preferred qualifications:
- Experience working with suppliers or in supply chain management.
- Experience working in the Medical Device Field.
- Excellent communication and project management skills.
- Strong bias for action and results oriented.
- Self-driven and self-motivated to learn and apply knowledge to produce results.
- Good understanding of statistical methods, six sigma methodologies, and problem-solving methodologies.
Quality Systems Duties and Responsibilities: Build Quality into all aspects of their work by maintaining compliance to all Quality System requirements.
WORKING CONDITIONS:
- May on occasion be exposed to loud sounds and distracting noise levels, such as from office equipment.
- The ability to lift up to 30lbs
- Use of computers and technology
Here at Canon Recruiting, People are our priority, and we are committed to Include Diversity in every segment of who we are. It is only through our Diversity, we are made a stronger organization, and increase our ability to provide top tier candidates that our clients have come to know Canon for. We have an inclusive environment all employees are celebrated for their unique differences. The different perspectives and experiences of our workforce give us the competitive advantage that is essential for success in an ever-changing market. By promoting inclusion with the same enthusiasm, we devote to quality and competency, and using the experience from a diverse assortment of backgrounds and experiences, Canon is able to improve the services and value we deliver to clients, employees, and customers. At Canon, Diversification and Inclusiveness are much more than a corporate ambition; they are a critical component in our daily corporate life.
Canon Recruiting is committed to a diverse and inclusive workplace. Canon Recruiting is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.
The pay range for this position is listed above. Base pay information is based on market location.
We will consider for employment qualified applicants with arrest and conviction records. Our range of benefits may include health care and 401(k) savings plans.
For individuals with disabilities who would like to request an accommodation, please email hr@canonrecruiting.com