Pocasset, Massachusetts — GII is seeking a savvy, upbeat individual with proper industry experience to fill our Director of Quality position. Below are the details of the position:
JOB TITLE: Director of Quality
REPORTS TO: President, CEO
As Director of the Quality Team, the Director is responsible for driving the quality objectives of Global Interconnect, Inc. The Director of the Quality ensures that processes needed for the Quality Management System (QMS) are established, implemented, and maintained in accordance with ISO 9001 and ISO 13485 standards. This position reports to top management on the performance of the QMS and serves as the liaison between external accreditation bodies and customers in the way of organizational audits.
DUTIES AND RESPONSIBILITIES
The following represents a list of essential duties and responsibilities. Other duties may be assigned as required.
- Lead day to day oversight of GII’s QMS in accordance with ISO 9001 and ISO 13485 standards. More specifically to ensure the following:
- Records are established and maintained to provide evidence that the QMS is being followed
- Performance of the QMS is reviewed and remains aligned with business objectives
- Suppliers used by GII are qualified, evaluated, and re-evaluated to ensure quality standards are met and that records are properly maintained
- CAPA strategies with manufacturing partners are assessed and reviewed for effectiveness
- Internal audits are scheduled and being conducted to continually assess the effectiveness of the QMS
- Review of corrective and preventative action are performed for effectiveness
- As required, travel to GII’s Hong Kong and China Offices to ensure QMS objectives are being met
- Drive QMS not just internally, but across extensive network of manufacturing partners
- Initiate and drive problem resolution and product disposition with day to day decision making authority in the areas of quality assurance for the organization.
- Oversee root cause/failure analysis activities and manage corrective actions for material non-conformances utilizing established quality engineering techniques.
- Responsible for direct customer interaction, as required, to foster positive customer relations and effectively communicate GII’s quality standards.
- Serve as primary point of contact/management representative for all customer and external regulatory/assessment audits.
- Coordinate continual improvements of the QMS while monitoring the regulatory environment for changing policies, processes and procedures.
- Successfully work with project teams both within GII and outside the organization to drive project milestones and company objectives, as they relate to quality.
III. JOB IMPACT
The Director of Quality will have an important impact on the success of the Company by overseeing and maintaining the quality management system of the organization and upholding the highest level of commitment to product quality and customer support.
The Director of Quality carries out assigned responsibilities under the direction of the President in accordance with Company policies
To perform this job successfully, an individual must be willing and able to perform each essential responsibility satisfactorily.
- Bachelor’s degree or equivalent experience preferably in engineering or science
- 7-10 years direct experience in Quality Assurance in ISO 9001/ISO 13485 regulated industry with at least 2 years in a management position in Quality
- Understanding and command of FDA Registration process (Title 21 CFR Part 807)
- ISO Auditing experience
- ASQ-CQE preferred
- Trained internal auditor
- Statistical Process Techniques, Failure Analysis, and Process Validation experience
- Strong communication skills both written and verbal with internal and external constituents
- General knowledge of Mechanical and Electrical Engineering a plus
- Ability and willingness to travel domestically and internationally as required
- Charismatic champion of Quality with a professional drive to win.
- Ability to read, analyze and interpret general business, technology and professional journals, technical procedures and governmental regulations.
- Ability to write reports and business correspondence.
- Ability to effectively present information and respond to questions.
- Must be able to evaluate situations practically both from a business perspective and a quality perspective
- Ability to define problems, collect data, establish facts, and draw valid conclusions
Other Skills and Abilities:
- Able to work with computer hardware and software applications
- Strong organization skills
- Strong analytical skills
- Effective interpersonal skills
- Ability to foster cooperative team building relationships with all company personnel
- Demonstrated ability to tactfully handle difficult situations
- Consistently demonstrate ability to recognize and deal with priorities
- Perform all duties in an independent and professional manner
Physical and Practical Requirements:
- Must be able to see to read fine print.
- Must be able to communicate utilizing a telephone.
- Mobility to allow access to all parts of the office.
- Must be willing and able to learn all necessary computer functions.
- Must maintain a valid Driver’s License
- Must be willing and able to travel both domestically and internationally using common carriers.
MEASURES OF PERFORMANCE
- Optimize the success of the Company by working to ensure that customer specifications and expectations are achieved.
- Consistently achieve established Company and Departmental goals.
- Consistently accomplish project milestones
- Consistently supports all customers and services effectively as required
- Works to successfully retain existing customers and supports the acquisition of new ones.
VII. JOB COMPENSATION
The position of Director of Quality is compensated on an Exempt salary basis, as determined by the President and Chief Operating Officer.
I have reviewed the Job Description for the position of Director of Quality for Global Interconnect Inc. I have read and understand the authority, duties and responsibilities and other aspects of the Job Description. I further understand that this Job Description will form the basis for the periodic evaluation of my performance.
It is understood that this Job Description is a summary of the primary responsibilities of the position. It is not intended to be a complete and total description of each and every duty and responsibility of the position as may be necessary.
It is understood that the Company retains the right to change this Job Description at any time, for any reason at its sole discretion.
About Global Interconnect: GII is a team of engineers providing custom cable and wire solutions based outside of Boston, MA. Founded in 1995 GII has consistent revenue growth supporting some of the world’s leading medical device and high-end industrial companies. You can learn more about our products and solutions by contacting Colin Angle, Digital Marketing Manager, at (508) 563-6306 EXT 122 or by going to our new website: www.GlobalInterconnect.com.