Director of Quality

Summary:

Responsible for the development and administration of Seabrook’s Quality Management System and resources required to support FDA Quality Systems Regulation 21 CFR part 820, ISO 13495 and other applicable standards.

Essential Duties and Responsibilities:

• Primary interface with customers, suppliers and regulatory agencies during audits and for other quality and regulatory matters.
• Oversee activity of the Quality Control team. Identify and implement strategies to assure high level of outgoing product quality in line with quality objectives.
• Respond to customer requests for information on product configuration.
• Review and approve customer Quality Agreements. Assure that company procedures are updated to encompass the requirements in the agreements.
• Review and approve Engineering Change Orders. Assure that customer change requests are submitted and approved by customers in line with customer procedures and Quality Agreements.
• Manage process for handling customer drawings and specifications. Assure that they are available at point of use and that company practices are in line with customer requirements.
• Monitor performance and execution of the Quality Management System and quality of the product. Report any concerns to Executive Management.
• Keep abreast of new regulatory requirements and customer initiatives and lead projects require to maintain regulatory, business and customer compliance.
• Designated as a Member of Management with Executive Responsibility and assigned tasks as outlined in SOP-116.
• Participate in the development and realization of corporate Quality Policies and Objectives. Includes methods and systems to monitor and report on performance of Quality Management System and customer satisfaction.
• Provide leadership and development of quality department personnel.
• Develop and participate in quality system training programs
• Initiate, monitor and help to drive Continuous Improvement programs, company wide.
• Responsible for assuring that assigned activities are performed in accordance with Seabrook Quality System procedures.

Education and Experience:

• A minimum of a Bachelor's degree is required, preferably in a scientific discipline. Equivalent related experience may be accepted
• 5-10 years hands-on experience with quality systems supporting medical device manufacturing. Experience with machined/mechanical components a strong plus
• 3-5 years management experience
• In depth working knowledge of FDA 21 CFR Part 820; Quality System Regulation
• Familiar with ISO 13485 Medical device directive
• ASQC and/or ASQE certification a plus
• Proficient with MS Office applications
• Six Sigma Black Belt or Green Belt training a plus

Job Knowledge, Skills and Abilities:

• Must have strong leadership and decision-making skills with the ability to work constructively in difficult situations both internally and externally (with customers and suppliers).
• Strong verbal, writing, communication, and computer skills.
• Strong analytical and problem solving skills with good experimental and documentation habits
• Strong multitasking skills with the ability to work in a highly dynamic environment
• Detail oriented with a high level of emphasis on accuracy and completeness

Physical Demands:

• Light to moderate physical exertion required
• Regularly required to stand, reach and move about the facility
• Lifting/carrying Maximum lbs: 25

EEO Disclaimer:

ARCH Global Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success.  All employees of ARCH Global Precision are employed on an at-will basis. This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.