EG10 - Engineering Manager
Kelly Services eAccounts, Southborough Massachusetts
Senior Quality Engineer
3-4 month contract
48.61 - USD 55.56 per hour
- Cross-Functional Team member to support new product development, procurement, manufacturing and servicing processes representing Quality Engineering discipline
- Completes assigned Quality Engineering tasks to schedule.
- Promotes awareness of Quality and Regulatory requirements.
- Leads or participates in the development of process and procedure development/changes.
- Applies statistical process control (SPC) methods to evaluate current processes and process changes.
- Develops new approaches to solve problems identified as part of the team.
- Assist in the implementation, compliance, and maintenance of standards (e.g., FDA, ISO13485) and OGA Quality policies and procedures.
- Trains location personnel on all aspects of the Quality System and regulatory standards.
- Serves as a mentor for the Quality team to assist in developing Quality Engineering skills.
- Applies the requirements of the Quality System to processes, products or services for the location.
- Supports the manufacturing line to address quality issues and resolution.
- Support to metrology and preventive maintenance programs.
- Supports validation and verification strategy for new and existing products and processes as assigned.
- Leads the development and maintenance of Master Validation Plans.
- Participates in the CAPA process as required as an assignee or project team member.
- Investigates escalated product complaints to root cause to ensure timely customer response and correction.
- Monitors product and process performance metrics and acts upon trends (positive or negative).
- Leads MRB as a team member to ensure proper disposition of non-conformances.
- Authors, collaborates, and approves Quality System documentation including change orders, DHF, DMR, DHR, labels and labelling, etc.
- Conducts internal, vendor, and process audits to schedule.
- Interfaces with suppliers to resolve Quality issues
- Develops and drives measurable Quality improvements relating to products, processes and services.
- All other essential related duties as required