NATIONAL MOLDING LLC Looking for Quality Engineer at Largo, FL Full Time

DEPARTMENT MISSION STATEMENT: Provide efficient, cost effective, and relevant support resources and functions to all areas of the corporation by encouraging well-trained and empowered employees to strive for continual skill-set and process improvements while providing excellent customer service and corporate administration.

Responsibilities and Duties

1. Works with the various internal teams to ensure the overall quality of the product by making sure that processes are performed correctly using the right tools, materials, and processes.

2. Manages projects, including creating/updating documentation, aimed at improving product quality and process reliability and conduct statistical analysis of data.

3. Provides validation support by applying manufacturing tools such as FMEA, IQ, OQ, PQ, control plans, and gage R&R.

4. Leads CAPA teams and responsible for defect reduction by investigating root cause, determining corrective and preventive actions, and dispositioning nonconforming product.

5. Communicates quality issues with peers, managers, customers, and suppliers.

6. Performs ISO audits, as assigned.

7. Backs up the QC Supervisor, as needed.

8. Performs other tasks as assigned by the Quality Manager.

Qualifications and Skills

1. Knowledgeable in ISO 9001, ISO 13485, ISO 14971, and FDA 21CFR820 including Lead Auditor training.

2 Excellent problem-solving and observational skills.

3. Works independently with little or no supervision, dependable, hardworking.

4. Experienced with Geometric Dimensioning & Tolerancing (GD&T) and able to interpret blueprints/specifications. Also, experienced in the use of basic measuring devices such as: micrometers, calipers, torque testers, thread gages, go/no go plug gages, gage blocks, and scales.

5.Able to develop work instructions and forms and collect data on spreadsheets, proficient knowledge of Microsoft Office software and Mini Tab.

6. Communicates well with peers and others within the organization to promote continuous improvement.

7. Excellent attention to detail and pride in workmanship.

Education/Experience/Certifications:

1. Bachelor’s degree in engineering field (quality, mechanical, industrial preferred), or associate’s degree as Quality Engineer or at least 5 years experience as Quality Engineer.

2. At least 3 years previous medical device quality-related field experience, required.

3. ISO 9001, ISO 13485, ISO 14971, and FDA 21CFR820 Lead Auditor training, preferred.

4. Certified Quality Engineer (ASQ), preferred.

Job Type: Full-time

Pay: $70,000.00 – $100,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

COVID-19 considerations:
Optional mask face and social distancing at work

Ability to commute/relocate:

• Largo, FL 33773: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Able to successfully pass the criminal and drug screens

Education:

• Bachelor’s (Required)

Experience:

• ISO 9001: 3 years (Required)
• Quality management: 3 years (Required)

Work Location: One location