Quality Director

Quality Director
Westborough, MA 01581
Hybrid
Due to ITAR and/or CUI compliance, this position requires candidates to be U.S. citizens.

The Quality Director manages the quality organization, develops quality policies, generates quality reports, and provides support to organizations within the Company on quality-related issues.

WHAT YOU WILL BE DOING

• Adhere to all ESD requirements and Board Handling.
• Use of Moisture Sensitive Device (MSD) handling requirements based on component moisture sensitive levels (MSL).
• Collect information needed for disposition of nonconforming products, MRB chairperson.
• Quality planning as it relates to process and product, for both the site and the corporation as a whole.
• Plan and coordinate quality improvement efforts.
• Manage ISO certifications (including 9001; ISO 13485 and AS 9100) and changing requirements.
• Management Representative for ISO9001, AS9100 and ISO13485.
• Support ISO14001 Environmental Management Standards.
• Act as one of the site Environmental Management Representatives to support ISO14001.
• Training - train and/or provide necessary training related to accept/reject criteria and workmanship standards.
• Responsible for the overall quality metrics of the company and target areas for continuous improvement.
• Development of quality policies and objectives.
• Control and maintenance of the Calibration System and preventive maintenance program.
• Work with suppliers to ensure their quality systems are acceptable.
• Maintain corrective action process and system, working with Engineering and Manufacturing.
• Develop quality measures that track performance and lead to continuous improvement.
• Focal point of 6S Lean Initiatives to promote awareness throughout the facility and relate it to the entire corporation.
• Implement new processes to improve throughput and reduce defects.
• Ensure the promotion of awareness of regulatory and customer requirements throughout the organization.
• Support and follow all ISO standards related to OnCore’s various Quality Management Systems. These systems may include, but are not limited to, quality, the environment, health, safety and security.
• Support all corporate and site 6S objectives.
• Perform all other duties, as assigned.

WHAT IS NEEDED FOR THIS ROLE

• Bachelor’s degree in Engineering or similar discipline.
• 10 years of related experience.
• Ability to utilize electronic manufacturing system
• Knowledge of IPC-DVD-64C Component Identification.
• Ability to train to PC-A-610.
• Proficiency in Microsoft Office Suite.
• Knowledge of all relevant IPC work standards.
• Understanding of business administration.
• Understanding of World Class Manufacturing practices.
• FDA regulations and requirements.
• ITAR regulations and requirements.
• Experience and ability to manage a large staff and multiple concurrent technical projects is required.
• The ability to interact in multi-functional teams and influence people to work together is essential.
• Balance of strategic thinking and strong analytical skills with ability to execute.
• Detail-oriented and strong written and verbal communication and presentation skills.
• Must be familiar with Microsoft Office applications.