Job Summary

Columbia Tech provides Time to Market Services at WARP SPEED™, including product development, manufacturing, global fulfillment and aftermarket services. Columbia Tech clients include innovation leaders in the life-science, bio-discovery, alternative energy, semiconductor, power management, LED, medical, data storage, homeland security and robotics and automation industries. Columbia Tech is a subsidiary of Coghlin Companies, Inc., a fourth generation, privately held concept to commercialization firm. Columbia Tech was named one of the “Best Places to Work” in 2017, and the team works hard to maintain a culture and environment built on trust, respect, continuous improvement, and innovation.

Manage and enhance the Quality Management System (QMS) of Coghlin Companies through Supplier Development initiatives and for implementing quality related-programs and projects. Lead Supplier Quality improvement efforts designed to ensure continuous quality improvement.

Duties and Responsibilities

Ensuring that supplier quality requirements are effectively established and effectively maintained in accordance with all applicable standards and regulations.

Report to the General Manager and the Management Team, a minimum of twice a year, on the performance of supplier quality and any need for improvement.

Promote awareness of customer, statutory, and regulatory requirements throughout the organization.

Continuously develop, implement and oversee supplier quality assurance and supplier regulatory compliance for the company.

Maintain ISO 9001 or ISO 13485 certification.

Provide leadership and management for the Supplier Quality team for Columbia Tech and Cogmedix.

Lead the effective development, implementation and training of all Quality System procedures, work instructions, and forms to ensure compliance to ISO 9001 or ISO 13485.

Establish and maintain employee training.

Establish and maintain production monitoring systems for Suppliers and corporate auditing systems.

Manage response to all Supplier Corrective Actions (SCARs).

Analyze and report Supplier quality data for trends on a monthly basis.

Assist in interpretation & implementation of global standards requirements.

In partnership with senior management, identify and implement company regulatory strategies and standards in alignment with short and long term business plans.

Review technical publications, articles and abstracts to stay abreast of current regulations and trends, ensure appropriate actions are taken to incorporate necessary revision into workplace environment.

Responsible for assuring adherence to various governmental policies, regulations, standards, procedures and guidelines under which the company must operate in regards to supplier quality and compliance. Specifically, this person may initiate action to prevent non-compliance; identify and document quality problems and subsequently initiating, recommending, providing and verifying solutions to product problems.

Actively leads and participates with the Senior Vice President, Corporate Quality & Compliance in Company, and other regulatory inspections, including responding to observations, securing agreement of corrective actions, and overseeing the implementation of corrective actions.

Maintains current knowledge and expertise of applicable regulations.

Consistently identifies strategic regulatory opportunities and threats to ensure company has focused appropriate resources to maximize success.

Coordinates all activities pertaining to meetings and conferences with regulatory agencies, and communicates outcomes to senior management as appropriate.

Provide support to the company during internal & external audits.

Identify, report, and recommend solutions to general compliance issues that may arise through the work process.

Support and lead continuous improvement activities.

Other duties as assigned.

Qualifications

B.S. degree in Mechanical or Manufacturing Engineering desired.

Positive attitude, self-motivated, tenacious follow up, and superior organization skills.

Superior customer service attitude.

Bachelor’s degree – Significant professional experience may be considered in lieu of certain educational requirements.

10+ years of experience and knowledge with implementation and maintenance of an ISO 9001 or ISO 13485 Quality System.

Experience with managing quality groups.

Strong interpersonal skills; must be capable of effectively establishing professional rapport with internal personnel, various levels of management, and external partners.

Effective organizational, communication, presentation, and writing skills.

Thorough understanding of manufacturing quality process controls and statistical methods.

History of effective interactions with FDA and Notified Bodies, preferred.

Working Environment

Generally works in an office environment, but may occasionally be required to perform job duties outside of the typical office setting.

Physical Requirements

Must have a reliable form of transportation and ability to travel to other company locations.

Flexibility to work extended hours when needed.

Note: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and/or skills required of all personnel so classified.

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled_