Senior Quality Assurance Manager

Senior Manager, Quality Assurance

This role is responsible for driving quality processes and practices throughout the entire product lifecycle, from initial design to end-of-life. Our client is looking for a Senior Manager who will collaborate closely with Manufacturing Operations, Engineering, and parts suppliers to ensure the delivery of robust products that meet company objectives for manufacturability, cost, quality, and on-time delivery.

The ideal candidate will possess a strong track record in the Manufacturing of electromechanical systems and PCBAs.

Candidates are required to be located within commutable distance to Lawrence, MA.

Key Responsibilities:

• Quality Assurance in Manufacturing: Verify proper specification and inspection of components and finished goods. Ensure manufacturing processes are well-designed, analyzed, and validated.
• Supplier Quality Management: Evaluate component and sub-assembly subcontractors to guarantee hardware quality and adherence to relevant standards and regulations.
• Process and Quality Planning: Partner with the Plant Manager to develop, implement, and maintain essential documentation such as Process Flows, Control Plans, Measurement System Analyses (MSAs) and Quality Plans.
• Inspection and Testing: Establish and implement adequate inspections, test methodologies, and sampling plans to confirm supplier parts and assembled products meet specifications and expectations.
• Technical Expertise: Provide technical guidance in conducting Process Failure Mode and Effects Analyses (PFMEAs) with Suppliers and in developing process validations.
• Supplier Change Management: Ensure proper approval, documentation, and communication of Supplier Change Requests.
• Problem Solving and Failure Analysis: Support quality metrics and provide leadership in resolving issues, and conduct failure analysis with manufacturing partners and component suppliers.
• Design for Manufacturability (DFM): Support DFM initiatives both within company and with manufacturing partners.
• Mechanical Design Support: Offer guidance and support to the mechanical design team to facilitate successful new design introductions at mechanical fabrication vendors, including First Article Inspection and First Off Tool Sample approval.
• Root Cause Analysis and Corrective Actions: Conduct thorough root cause investigations for product quality issues and implement appropriate corrective and preventive actions. Investigate and report on field quality issues and product failures, leading cross-functional resolution efforts.
• Reliability Monitoring: Calculate and monitor the Mean Time Between Failures (MTBF) of designed products and recommend improvements to enhance reliability.
• ISO Certifications: Conduct timely audits of our ISO 9001 and ISO 14001 for compliance as well as process improvement.

Required Qualifications:

• Bachelor's or master's degree in industrial engineering, Mechanical Engineering, or a related technical field with a strong background in electromechanical and electronics assembly.
• Minimum of 7 years' experience as a quality manager overseeing quality control, developing and implementing quality systems, and ensuring compliance with regulations and customer requirements.
• Minimum of 10 years of experience in Quality Assurance/Quality Engineering roles focused on Manufacturing assembly operations. A broad knowledge of mechanical/plastics parts manufacturing is desired.
• Proven experience in transitioning products from the design phase into manufacturing.
• Solid engineering knowledge in FMEA, Statistical Process Control (SPC), Process Characterization, and Gage Repeatability and Reproducibility (GR&R).
• Familiarity with IPC610 guidelines and ISO standards.
• Strong foundation in Manufacturing Engineering, Design for Manufacturability, and New Product Introduction processes.
• Proficiency in utilizing analytical tools and methods, including statistics (Minitab preferred), Design of Experiments (DOE), and relevant computer software for design, development, and manufacturing.
• Highly self-motivated with a demonstrated ability to lead teams effectively without direct authority.
• Willingness and ability to travel approximately 15–30% of the time for supplier visits or business meetings, both domestically and internationally.

Preferred Additional Skills and Qualifications:

• Experience working with Tier 1 and 2 EMS or CM providers.
• Knowledge of Lean Manufacturing principles.
• Six Sigma Black Belt certification.