What are the responsibilities and job description for the Supplier Quality Engineer position at Medical Engineering Consultants (MEC)?
Job 2596 - Supplier Quality Engineer - Contract located near Minneapolis, Minnesota
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
About The Role
This project addresses a CAPA related to our client's 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 and Quality Engineering 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 our client's expectations. This evaluation and remediation cycle will be repeated across all applicable contract manufacturers until all required supplier processes have been fully addressed.
This Supplier Engineer will be responsible for the remediation activities identified by a CAPA for our client's contract manufactured (CM) sourced finished medical device (SFMD) products. This individual works independently, serves as a leader for SQE remediation activities and interacts cross-functionally with team members and Contract Manufacturers (SFMD) suppliers to execute deliverables according to business needs.
Responsibilities Include
Build Quality into all aspects of their work by maintaining compliance to all Quality System requirements.
MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
About The Role
This project addresses a CAPA related to our client's 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 and Quality Engineering 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 our client's expectations. This evaluation and remediation cycle will be repeated across all applicable contract manufacturers until all required supplier processes have been fully addressed.
This Supplier Engineer will be responsible for the remediation activities identified by a CAPA for our client's contract manufactured (CM) sourced finished medical device (SFMD) products. This individual works independently, serves as a leader for SQE remediation activities and interacts cross-functionally with team members and Contract Manufacturers (SFMD) suppliers to execute deliverables according to business needs.
Responsibilities Include
- Review, remediate and approve CM SFMD suppliers process risk documentation (PFMEA) to newly defined criteria.
- Review, remediate and approve CM SFMD suppliers process and inspection validations to statistical requirements.
- Perform change management activities to remediate gaps found in CM SFMD Suppliers process risk documentation and process/inspection validations.
- Collaborate with CM SFMD suppliers and functional resources to complete all activities needed to approve suppliers 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.
- Bachelors 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 but could be international.
- 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.
- Candidate MUST have good communications skills.
- Cannot be afraid to pick up the phone
Build Quality into all aspects of their work by maintaining compliance to all Quality System requirements.
MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.
- Sponsorship is not available for this position
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.