Quality Process Improvement Engineer

Reposted 21 Days Ago
Be an Early Applicant
Georgetown, TX
In-Office
Senior level
3D Printing • Healthtech • Biotech
The Role
The Quality Process Improvement Engineer drives data-driven initiatives to enhance product quality, process capability, and manufacturing consistency, focusing on reducing waste and rework.
Summary Generated by Built In


The Quality Process Improvement Engineer plays a key role within CelLink’s Quality organization, driving data-driven initiatives that enhance product quality, process capability, and manufacturing consistency. This role focuses on identifying sources of variation, improving upstream quality, and implementing sustainable solutions that reduce waste, rework, and defects. Working cross-functionally with Manufacturing, Process Engineering, and Operations teams, this engineer ensures that process improvements not only increase efficiency but also strengthen quality systems, compliance, and overall customer satisfaction.

  • Lead quality-driven process improvement projects to increase yield, reduce defects, and improve traceability.
  • Apply Lean, Six Sigma, SPC, and root cause tools (e.g., 8D, DOE) to eliminate variation and implement effective CAPAs.
  • Support and enhance incoming, in-process, and outgoing quality controls (IQC, IPQC, OQC) to meet standards and customer specs.
  • Build and maintain dashboards to monitor key metrics: FPY, scrap, DPPM, rework, and audit results.
  • Develop and maintain FMEAs, control plans, inspection plans, and standardized work instructions.
  • Ensure process documentation and changes align with ISO, IATF, and customer quality requirements
  • Partner with engineering, operations, and suppliers to drive sustainable improvements and validate corrective actions.
  • Support NPIs with robust validation and smooth production handoff.
  • Coach staff on quality methodologies and foster a culture of continuous improvement and compliance.

Minimum Qualifications

Experience/Education

  • Bachelor’s degree in Engineering or related technical field required; Master’s degree preferred.
  • Certifications such as Six Sigma Green/Black Belt, ASQ CQE, or ISO Lead Auditor are highly desirable.
 

Knowledge/Skills/Abilities

  • 5–8 years of experience in quality engineering, process improvement, or manufacturing roles, ideally within high-volume or regulated industries (automotive, electronics, or medical device).
  • Proven record of leading data-driven quality improvement projects that reduced variation and improved yield.
  • Hands-on experience with SPC, FMEA, MSA, DOE, and other statistical or Lean tools.
  • Familiarity with quality management systems (ISO 9001, IATF 16949) and audit processes.
  • Strong analytical and statistical background; capable of turning data into actionable insights.
  • Excellent communication and leadership skills with a collaborative, solution-oriented mindset.
  • Proficiency in Microsoft Office and data visualization tools (Power BI, Minitab, or JMP).
  • Ability to thrive in a fast-paced, cross-functional, and hands-on environment.
 

Location

Position is 100% based onsite at CelLink in Georgetown TX, with occasional travel to Suppliers and Customers as needed.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

Working Conditions/Hours

Salaried Exempt

Physical Demands – Office and Manufacturing Environment

While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or finger, handle, or feel objects, tools or controls. The employee is required to stand; walk; sit; reach with hands and arms and pull/push; climb or balance; and stoop, kneel, crouch, or crawl. The employee must lift and/or move up to 50 pounds without assistance. Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision, and the ability to adjust focus.

Work Environment – 

Includes both a typical office environment, with minimal exposure to excessive noise or adverse environmental issues, and a shop environment, with exposure to high noise levels from operating machines, physical hazards from moving equipment and machine parts, nuisance dust, and skin exposure to chemicals used to run/maintain machines

PPE-

May be required to wear Personal Protective Equipment, including but not limited to safety glasses, safety shoes, bump-caps, gloves, hair nets, masks, & clean-room frocks while adhering to the prescribed safety procedures.

We believe diversity and inclusion among our teammates are essential to our success. We celebrate diversity and are committed to creating an inclusive environment for all employees while building teams that represent a variety of backgrounds, perspectives, and skills. We are an equal opportunity employer. All employment is decided based on qualifications, merit, and business needs. CelLink participates in the E-Verify program in specific locations as required by law.

CelLink was founded in 2012 and entered volume production in 2018. CelLink provides electrical systems to the world's leading EV manufacturers, traditional automotive OEMs, and tiered suppliers. The company has raised approximately $315M in funding through private investment and multiple grants from the US Department of Energy. CelLink’s investors include 3M, Atreides, BMW, BorgWarner, Bosch, D1 Capital, Fidelity, Fontinalis Partners, Ford, Franklin Templeton, Lear, Park West, SK Telecom, Standard Investments, T. Rowe Price, Tinicum, and Whale Rock

Top Skills

8D
Control Plans
Doe
Fmea
Inspection Plans
Jmp
Lean
MS Office
Minitab
Power BI
Six Sigma
Spc
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The Company
Boston, MA
201 Employees

What We Do

CELLINK is proud to be a part of BICO, the world’s leading bioconvergence company. By releasing the first universal bioink in 2016, CELLINK democratized the cost of entry for researchers around the world and played a major role in turning the then up-and-coming field of 3D bioprinting into a thriving $1 billion industry. The company’s best-in-class bioinks, bioprinters, software and services are trusted by the foremost academics in a range of applications, from 3D cell culturing to tissue engineering to drug development, and have been cited in over 700 publications. Furthermore, more than 1,000 laboratories, including ones at the top 20 pharmaceutical companies, are using these award-winning innovations. As part of BICO’s bioconvergence revolution, CELLINK is dedicated to making the on-demand bioprinting of human organs and tissues a future reality and creating the future of health.

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