Manufacturing quality engineer job description

Cornerstone Staffing Solutions, Inc. is looking for a Quality Manufacturing Engineer to work for our client in Lapeer, MI. This is a DIRECT HIRE opportunity! Pay will be based on experience, up to $70K.

The Quality Manufacturing Engineer is responsible for building collaborative relationships between the supplier, customer and plant, implementation and improvement of statistical methods, quality cost analysis, specification and procedure development, following ISO/IATF requirements, effective problem solving and assisting with plant quality audits. Work with the production departments to eliminate Quality defects through the analysis of data and the implementation of Poka-Yoke systems in the manufacturing process. Responsible for maintaining the quality and integrity of the products assigned in order to meet customer’s requirements / expectations.
ESSENTIAL FUNCTIONS:
1. Analyze the customer complaint information to develop perato charts in order to set priorities
2. Analyze and drive scrap reduction projects within each department
3. Support Operation departments with quality meetings, problem solving, reject/defect (DMR) investigations associated with internal processes and purchased parts.
4. Assist in writing project charters based on Quality defects which were analyzed
5. Assist in finding root cause of customer concerns
6. Assist in writing 8D’s based on the root cause analysis and 5-why process
7. Work with supplier on SCAR and continual improvement
8. Assist in conducting annual plant audits (VDA, LPA and IATF) systems surveys, assist in providing feedback to improve Quality procedures and systems.

ADDITIONAL RESPONSIBILITIES:
1. Participate as an active member of one of the KPM / TPM pillar teams
2. Track ongoing Quality projects and report on progress monthly
3. Review and assist in validation process used for closed 8D’s
4. Review improvement projects with customers during plant tours
5. Review SPC data to understand production process limits and recommend improvements from this data
6. Performs other duties as assigned.

The Manufacturing Quality Engineer serves as the lead quality representative of assigned product lines for new product development, day to day manufacturing support, non-conformance, and acts as the independent review function. The Manufacturing Quality Engineer supports additional process such as Supplier Quality, Internal Audit, CAPA, and Post Market Surveillance. The Manufacturing Quality Engineer fulfills the role of both contributor and independent reviewer for their assigned product lines.
Responsibilities

- Perform work per external and internal quality standards.- Perform independent review function per external and internal quality standards.- Interface with internal and external groups on quality-related issues.- Be the voice of quality for daily manufacturing in assigned departments by partnering with Operations and Production Engineering and providing guidance on issues in line with external standards, internal standards, and best practices.- Support product development and transfer to manufacturing.- Facilitate development and implementation of production processes and controls. (e.g. qualification, process capability, sampling plans, validation, etc.)- Assist with investigation of product non-conformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues.- Own quality improvement tasks in assigned departments.- Plan, draft, and route change requests as necessary.- Execute risk assessment as needed and facilitate development and completion of risk file documentation.- Support CAPAs as necessary.- May interface with internal or 3rd party audits. (e.g. FDA, Notified Body, etc.)- Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including engineering, production, clinical, and regulatory affairs.- Provide leadership in the understanding of medical device regulations and best practices.- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.- Adhere to the Quality Management System and its processes to ensure compliance to FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.- Must strictly adhere to safety requirements.- Maintain regular and punctual attendance.- Must maintain company quality and quantity standards.- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.- Ability to remain calm and receptive in fast paced situations.

Qualifications

- Bachelors degree in engineering or scientific discipline- >2 years of engineering experience. Any engineering discipline if coming from a medical device background -OR- quality engineering experience from any regulated industry.- Knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971) is preferred but will consider a candidate with quality experience from any regulated industry.- Professional certification (e.g. ASQ, Six Sigma, etc.) preferred.- Proficiency in statistical, quality and continuous improvement methods and tools.- Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) is required.

Posting Date1 month ago(9/14/2022 2:46 PM)


Job Location(s) Bloomington IN United States

Travel Less than 10%

Position Type Full Time

Company Cook Inc - Bloomington

Category Quality

The Manufacturing Process Quality Engineer will ensure that all processes that are conducted as part of the assembly, bring-up, and End-of-Line (EOL) testing of our vehicles will meet the high-quality standard of Zoox. This includes the development and implementation of In-Line and End-of-Line quality checks as well as driving the root cause resolution of any issues that occur during the manufacturing process. As part of a daily routine, the Manufacturing Process Quality Engineer will interact with many different parties including Corporate Quality, Vehicle Engineering, Supplier Quality, and Software.

ResponsibilitiesDevelopment and integration of quality and functional checks into the manufacturing process Conduct root-cause analysis for any assembly related issues Development, implementation, and optimization of End-of-Line process Creating and maintaining of PFEMAsDevelopment and Implementation of control plans Analysis of quality data to improve the assembly and test process Work cross-functionally to help resolve supplier quality or design-related issues that occurred during the manufacturing process Contribute to the definition and improvement of Zoox Quality Policy and Manual.Create the procedures, instructions, and processes that will allow Zoox to align with the international standards for Quality Systems (IATF 16949, ISO 9000, and similar).

QualificationsEngineering Degree in the respective field (Manufacturing, Electrical, Mechanical, Industrial) Minimum 3 years of experience in quality/manufacturing engineering Experience with creating FMEA process / Control Plan / APQPAble to work fully independent with minimal supervision

Bonus QualificationsAutomotive OEM or Tier 1 supplier experience Process Improvement certification (Lean Six Sigma / Shainin) CATIA V5/V6 experience
Vaccine Mandate

Employees working in this position will be required to have received a single dose of the J&J/Janssen COVID-19 vaccine OR have completed the two-dose Pfizer or Moderna vaccine series. In addition, employees will be required to receive a COVID-19 booster vaccine by the earlier of (1) April 15 or (2) within two months of becoming eligible for the booster vaccine.

Employees will be required to show proof of vaccination status upon receipt of a conditional offer of employment. That offer of employment will be conditioned upon, among other things, an Applicant's ability to show proof of vaccination status. Please note the Company provides reasonable accommodations in accordance with applicable state, federal, and local laws.

About Zoox

Zoox is developing the first ground-up, fully autonomous vehicle fleet and the supporting ecosystem required to bring this technology to market. Sitting at the intersection of robotics, machine learning, and design, Zoox aims to provide the next generation of mobility-as-a-service in urban environments. We're looking for top talent that shares our passion and wants to be part of a fast-moving and highly execution-oriented team.

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A Final Note:
You do not need to match every listed expectation to apply for this position. Here at Zoox, we know that diverse perspectives foster the innovation we need to be successful, and we are committed to building a team that encompasses a variety of backgrounds, experiences, and skills.