Engineer, Manufacturing Quality & Process Control

Engineer, Manufacturing Quality & Process Control

Overview

We are seeking a highly skilled and results-oriented Engineer, Manufacturing Quality & Process Control to serve as our primary technical interface with our contract manufacturing partners. This is a critical, hands-on role focused on establishing and maintaining robust process control and product quality from the ground up. The ideal candidate will leverage their dual expertise in manufacturing engineering and quality assurance to define, implement, and validate the quality control framework for a new manufacturing line. This position is not a Quality Management System (QMS) management role; it is a technical execution role focused on process characterization, test definition, and control documentation.

Key Responsibilities

Process & Test Definition (Manufacturing & Quality Engineering)

• Define and Develop Test Methods: Own the technical definition and specification of all critical in-process and final product quality inspection/testing. This includes identifying key process parameters and the appropriate statistical control limits.
• Process Characterization: Lead or support the execution of Design of Experiments (DOE), Process Capability Studies (Cpk/Ppk), and Measurement System Analysis (MSA/Gage R&R) to ensure testing adequately characterizes the manufacturing process and product requirements.
• Equipment Validation: Work with the contract manufacturer (CM) to define and execute the necessary Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for new manufacturing and test equipment.

Quality Control Program Implementation

• Control Plan Development: Define and maintain the manufacturing Control Plan, including specifying necessary sampling plans, inspection frequencies, and acceptance criteria for critical-to-quality (CTQ) features.
• Non-Conforming Material (NCM) Management: Establish the criteria and documentation for identifying, isolating, and dispositioning non-conforming material, including defining root cause analysis (RCA) and corrective action processes for line excursions.
• Statistical Process Control (SPC): Implement and monitor Statistical Process Control (SPC) charts for critical process variables and train CM personnel on the appropriate response to out-of-control conditions.

Contract Manufacturer Liaison & Line Standup

• Technical Partnership: Act as the primary technical quality contact, ensuring the CM's production processes, documentation, and quality controls align with our engineering specifications and quality standards.
• Manufacturing Line Standup Support: Provide on-site technical support during the standup and ramp-up of the new manufacturing line, actively validating the process flow and control points.
• Documentation Control: Generate and manage all quality-related documentation, including specifications, process flow charts, inspection reports, and production sign-off criteria, ensuring the CM has the necessary documentation to keep the process in control.

Required Skills & Qualifications

• Education: Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Electrical Engineering, or a related technical field.
• Experience: 5+ years of combined experience in high-volume manufacturing engineering and/or quality engineering roles.
• Technical Expertise:
• • Strong expertise in statistical methods including DOE, SPC, and various Process Capability indices.
  • Deep understanding of Measurement System Analysis (MSA) and Gage Repeatability & Reproducibility (GR&R) studies.
  • Hands-on experience in defining and implementing manufacturing process controls, inspection/test fixtures, and line balancing.
• Documentation: Proven ability to create clear, concise, and complete technical documentation, including Control Plans, FMEAs, and Standard Operating Procedures (SOPs).
• Communication: Excellent interpersonal and communication skills to effectively collaborate with internal design teams and external contract manufacturing personnel.
• Travel: Ability to travel up to 25% (or as required) to support the contract manufacturer's site during line standup and qualification.

Preferred Qualifications

• Certification such as ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt.
• Familiarity with various international or industry-specific quality standards (e.g., ISO 9001, relevant medical device or automotive standards) and how to apply them technically to a manufacturing line.
• Experience in the scale-up from prototype to mass production (>10k units/month).

Disclaimer:   

We are an affirmative action, equal opportunity employer. Our employment decisions are made without regard to race, color, religion, gender, gender identity, national origin, age, disability, marital status, veteran or military status, or any other legally protected status.   

In accordance with the ADA, employees must perform the essential duties and responsibilities efficiently and accurately, with or without reasonable accommodation.  The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties and/or skills required of all personnel so classified.   

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