Quality Assurance Engineer

C&A Tool Engineering, Inc.; Auburn (IN); On-site; USD 28,000 - 40,000; Full time

Benefits offered by this job

Health insurance

Vision

Paid vacation

Company paid life insurance

Holidays

Tuition reimbursement

Job summary

C&A Tool Engineering, Inc. is seeking a qualified professional for a 100% on-site Validation/Quality role in Indiana. The candidate will lead IQ/OQ/PQ validation activities, develop validation plans, and support NPI and process optimization in a regulated manufacturing environment.

Required knowledge includes GD&T, metrology, GR&R, and regulatory compliance with ISO 13485 and FDA requirements, along with excellent communication skills and teamwork. On-site work and US citizenship are required.

Qualifications

• Bachelor’s degree in Engineering or related field with 3 years' experience.
• Knowledge of Quality and Medical Device regulations.
• Proficient with basic measuring instruments.
• Knowledge with GD&T and inspection methods.
• Knowledge with GR&R and capability studies.
• Excellent written and verbal communication skills.
• Strong knowledge of validation protocols and processes.
• On-site work required; US citizen at hire.

Responsibilities

• Lead IQ/OQ/PQ validation activities for equipment, processes and product introductions.
• Develop, review, and approve Validation Master Plans, protocols and reports.
• Support Design/Product Transfer, New Product Introduction (NPI) and process optimization projects.
• Maintain compliance with ISO 13485, FDA 21 CFR Part 820 and other applicable regulations/standards and internal quality system procedures.
• Drive root cause investigations and implement effective CAPA.
• Support internal audits, supplier audits and regulatory inspections as needed.
• Analyze quality data trends and recommend improvements to reduce defects and nonconformances.
• Ensure lot traceability, documentation accuracy and compliance with Device History Records (DHR).

Skills

GD&T

Metrology

Validation

GR&R

Inspection methods

Measuring instruments

Quality systems

Communication skills

On-site work

Regulatory knowledge

Education

Bachelor’s degree in Engineering

Associate degree in Technical Field with 3 years experience

Tools

Metrology equipment

Calibration instruments

Job description

C&A Tool a leading Advanced Manufacturer since 1969 of precision products for the Automotive, Aerospace, Fuel Systems, industrial and Medical Device markets is currently seeking qualified candidates. Operating three manufacturing facilities in Northeast Indiana (Auburn/Churubusco) and employing nearly 600 skilled workers, we are an integral part of a larger global manufacturing conglomerate, MinebeaMitsumi.

Those looking for a friendly/safe work environment, supporting employee growth through education, training, wellness programs and volunteering within the community are encouraged to apply.

"We measure our work in Microns, Experience in decades and our success due to our valuable Teammates"

Job Description

Compensation: $25/hr. and up Depending on Experience and/or Formal Training

• Health (HSA Option Available)
• Vision
• Paid Vacation
• Company Paid Life Insurance and Short-Term Disability
• Eligibility for additional: Short/Long-Term Disability, Accidental, Life, Critical Illness and Hospital Indemnity coverage
• Company Paid Holidays
• Tuition Reimbursement

Required Skills/Knowledge:

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, or related field) or Associate’s degree in Technical Field with 3 years minimum experience
• Knowledge of Quality and Medical Device regulations
• Proficient with basic measuring instruments
• Knowledge and experience with Metrology, GD&T and inspection methods
• Knowledge and experience with GR&R and capability studies
• Excellent written and verbal communication skills
• Strong knowledge of validation protocols and processes
• Ability to interact with all co-workers in a professional courteous manner
• Position is 100% On-Site
• Due to the nature of our work, will need to be a US Citizen at time of Hire

Additional Skills/Knowledge Preferred:

• Experience executing Validation protocols and reports will be highly considered
• Interpret technical information from manuals to support new product development and equipment setup
• Prepare detailed reports as requested
• Completion of required quality documents (complaints, non-conformances, etc…)
• Ability to interact with a diverse group of management, engineers, and technical staff whether internal or external customers
• Prepare and conduct experiments and record results
• Train operators with proper gaging technique and print interpretation
• Excel in time management, organizational, and problem-solving skills and demonstrate outstanding customer service skills
• Prioritization of work in accordance with manufacturing needs and Quality Manager feedback

Key Responsibilities:

• Lead and execute IQ/OQ/PQ validation activities for equipment, processes and product introductions
• Develop, review, and approve Validation Master Plans, protocols and reports
• Support Design/Product Transfer, New Product Introduction (NPI) and process optimization projects
• Maintain compliance with ISO 13485, FDA 21 CFR Part 820 and other applicable regulations/standards and internal quality system procedures
• Drive root cause investigations and implement effective Corrective and Preventive Actions (CAPA)
• Support internal audits, supplier audits and regulatory inspections as needed
• Analyze quality data trends and recommend improvements to reduce defects and nonconformances
• Ensure lot traceability, documentation accuracy and compliance with Device History Records (DHR)

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

Equal Opportunity / Affirmative Action Employer. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Qualified candidates must be able to perform the essential job functions with or without reasonable accommodation. Internal applicants should provide a resume and cover letter addressing their qualifications specific to the role.

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Employer Privacy Policy

MinebeaMitsumi and its affiliates including New Hampshire Ball Bearings, NMB Technologies Corporation, NMB USA, C&A Tool, the "Company", IS AN EQUAL OPPORTUNITY EMPLOYER AND PROHIBITS DISCRIMINATION AND HARASSMENT OF ANY KIND. ALL EMPLOYMENT DECISIONS AT the company ARE BASED ON BUSINESS NEEDS, JOB REQUIREMENTS AND INDIVIDUAL QUALIFICATIONS, WITHOUT REGARD TO RACE, AGE, CREED, RELIGION, COLOR, NATIONAL ORIGIN, ANCESTRY, CITIZENSHIP STATUS, SEX OR GENDER (INCLUDING PREGNANCY, CHILDBIRTH, LACTATION AND RELATED MEDICAL CONDITIONS), GENDER IDENTITY OR GENDER EXPRESSION (INCLUDING TRANSGENDER STATUS), SEXUAL ORIENTATION, MARITAL, MILITARY OR VETERAN STATUS, OR PHYSICAL OR MENTAL DISABILITY, PROTECTED MEDICAL CONDITION AS DEFINED BY APPLICABLE STATE OR LOCAL LAW, GENETIC INFORMATION, OR ANY OTHER CHARACTERISTIC PROTECTED BY APPLICABLE FEDERAL, STATE OR LOCAL LAWS AND REGULATIONS (REFERRED TO AS "PROTECTED CHARACTERISTICS").

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