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Lead Quality Assurance Engineer

2 months ago

Ramsey, United States Multisource Mfg Full time

POSITION OVERVIEW:


This is a proactive on-site role aimed at enhancing customer satisfaction and fostering sales growth by identifying and mitigating risks through effective detection and prevention strategies at both product and system levels.

The position necessitates a comprehensive understanding of Structured Problem Solving methodologies and Quality Control tools, facilitating the implementation and ongoing enhancement of these practices. The ability to prioritize effectively, drive accountability, and communicate in a precise and timely manner is essential.

This role demands a robust knowledge of pre-production documentation standards specific to the aerospace and medical device sectors.

The role frequently interacts with the new product introduction team, quality assurance team, front-line personnel, and occasionally customers, suppliers, and cross-functional leadership.


AUTHORITY:


This position is granted sufficient authority by the Quality Manager or designated representative to ensure the successful execution of assigned responsibilities.

The Lead Quality Assurance Engineer possesses the authority to take necessary actions to rectify deviations from the quality system or metrological procedures, provided such actions align with established company policies and reflect sound technical and business judgment.


KEY RESPONSIBILITIES:

  • Develop and implement quality protocols, control plans, production part approval processes (PPAPs), process failure mode effects analysis (PFMEAs), specifications, standards, data collection methodologies, metrics, and other quality tools to guarantee products meet or surpass customer expectations.
  • Collaborate closely with the new product introduction team to ensure a seamless transition of components from the quoting phase through to manufacturing and delivery to clients.
  • Guide and mentor other members of the Quality Assurance team to ensure timely execution of their responsibilities.
  • Act as the primary site liaison for customers, suppliers, and subcontractors concerning quality-related issues, which may involve coordination with other sites and limited travel.
  • Investigate failures to meet requirements, determine corrective and preventive actions based on risk assessments, and utilize structured problem-solving frameworks such as 8D to document and resolve issues.
  • Ensure prompt resolution of discrepant material reports (DMRs), client complaint investigations (CPAs), and other relevant reports.
  • Aim to maintain a minimal number of parts requiring active quality disposition and facilitate the smooth flow of materials through the process.
  • Design and recommend inspection and sampling techniques or other risk mitigation strategies for new and existing customers and components to minimize scrap, rework, and other process inefficiencies.
  • Provide technical support related to process capability, Gage R&R execution and investigation, new product introduction, defect detection and prevention, and process controls.
  • Coordinate and communicate plans and activities to foster a collaborative approach within the organization.
  • Communicate effectively and professionally with management and staff, both verbally and in writing.
  • Assist in training staff through local and online training programs.
  • Support variance reduction, troubleshooting, and improvement initiatives as required across the organization.
  • Ensure compliance with all guidelines, standard operating procedures (SOPs), and protocols of Multisource Manufacturing by site personnel.
  • Protect proprietary techniques from disclosure to non-employees unless explicitly approved in writing by the Leadership Team.
  • Maintain a state of readiness to respond to inquiries and needs from clients, staff, subcontractors, and colleagues.
  • Enhance the company’s reputation through the application of sound and ethical business practices in dealings with the public and customers.
  • Stay informed on technical, industry, and business developments as recommended by the Quality Manager and other Leadership Team members.
  • Perform additional duties as assigned and support the Quality Manager as necessary.

QUALIFICATIONS:

EDUCATION AND EXPERIENCE:

A six-year degree in a technical discipline with three years of experience or a four-year degree in a technical field with five years of experience.


  • Familiarity with regulated environments and requirements such as FDA, ISO, and AS9100.
  • Experience with audits involving external clients, regulatory agencies, and internal assessments.
  • Demonstrated expertise in Statistical Process Control (SPC), Gage R&R, Geometric Dimensioning and Tolerancing (GD&T), PFMEA, Design of Experiments (DOE), PPAPs, Control Plans, and qualification processes such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Understanding of manufacturing and assembly techniques, including fixtures, tooling, fabrication, and metrology.
  • Ability to analyze raw data and derive actionable conclusions and recommendations.
  • Proficient in Excel and other essential Microsoft Office applications.

SKILLS AND ABILITIES:

  • Ability to influence and communicate effectively (both written and verbal) with a diverse range of personnel and roles. Exceptional internal and external customer service skills.
  • Capable of conducting structured problem-solving, managing time efficiently, prioritizing competing demands, and escalating issues as necessary.
  • Quickly adapt to new concepts, software, interfaces, and tools.
  • Ability to translate minimal direction into actionable tasks, work independently, adapt to change, and maintain a curious and open-minded approach.

OTHER REQUIREMENTS:

PHYSICAL STRENGTH:
No heavy lifting is required.

LANGUAGE ABILITY:
Must be able to read and follow instructions in English.