Senior Medical Device Quality Engineer

greg — Sun, 05 Feb 2012 16:42:00 +0000

Springfield, MA- The Catalyst Recruiting Group www.catgroupinc.com is working with a growing, multi-national medical device client in their search for an innovative Senior Plant Quality Engineer This role will develop, implement and administer quality specifications, test methodologies, and sampling plans for product and process. Typical accountability:

Manage CAPA program and follow up on CAPA actions and due dates. Determine root cause/corrective and/or preventive actions for CAPAs. Mentor CAPA champion and team members.
Manage SCAR program, initiate SCARs, and track SCAR corrective actions and due dates.
Perform supplier audits and initiate/monitor follow up actions as required
Determine root cause/corrective and/or preventive action for customer complaints and externally generated customer SCARs
Six Sigma/Lean/Cost Savings Support
Manage and/or participate on quality improvement projects including collaboration with R&D, Marketing, Regulatory, Stability Services, and Clinical Affairs. Support cost savings projects. Use of statistical tools to perform analysis and data trending. Perform process risk assessment and failure mode effects analysis (PFMEA). Develop specifications and test methods to meet customer, product and internal quality requirements. This may include writing procedures to carry out requirements. Review new and modified product designs and processes for quality compliance.
Position maintains primary responsibility for critical quality systems including the internal audit program, CAPA system, and control of non-conforming product. This position is responsible for assuring overall regulatory compliance to the QSR and applicable Quality System standards.

REQUIRED Bachelors Degree. MDD and CMDR experience preferred. Project Management, SPC, DOE, FMEA

This position is going to be highly visible within this facility. They are looking for someone that can provide innovative problem solving abilities, motivate people, drive change and fully reflect the corporate goals/initiatives for lean manufacturing and continuous improvement. This is a role for a strategic planner that has quantifiable examples of affecting the bottom line, accessing risk through root cause analysis and acting as a “change agent” through an organization.

Our client is growing steadily both organically and though M&A. They are a global organization that offers outstanding growth potential. The benefits are outstanding and include generous 401k match, full tuition reimbursement, ESOP and much more. Relocation is being offered for this position.

After confirming that you meet the qualifications listed above, please send an email referencing this position title and location along with your resume and current/last base salary information to jon@catgroupinc.com. This information will be kept confidential and will allow our team to better understand the level and direction of your search. Under no circumstances will we submit your resume without your approval.

To apply, please email resume and current/last base salary to:

Jon Leifer
jon@catgroupinc.com
843-670-1619

Supply Chain Buyer-Planner-Manufacturing

greg — Sun, 05 Feb 2012 16:40:44 +0000

Springfield, MA- The Catalyst Recruiting Group www.catgroupinc.com is proud to be working with a growing advanced manufacturer in the Springfield, MA area who has promoted from within opening a Buyer position. This buyer will be focused on the manufacturing lifecycle of a specific product group within this site which will include raw materials purchasing. This role will work directly under the manufacturing manager in a small supply chain department. They are targeting that “go getter mentality” with outstanding communication ability and drive to take ownership.

REQUIRED 4 year degree, no exceptions, company policy. Quantifiable experience in manufacturing supply chain.

To apply, please email resume and current/last base salary to:

Jon Leifer
jon@catgroupinc.com
843-670-1619

Catalyst Recruiting Group » North East

Senior Medical Device Quality Engineer

Supply Chain Buyer-Planner-Manufacturing