Engineer - Quality Assurance-NL Quality Control

Job Title: Quality Engineer

Reports To:  Quality Assurance Supervisor

Job category:  Individual contributor  ☒          Management   ☐

Division: Home Care

Department: Quality

Location: Manitowoc, WI

Description / Scope / Mission

The purpose of the Quality Engineer is to help ensure all products produced by Northern Labs meets internal or external (i.e. customer or regulatory) requirements, that utilizes a broad scope to look at processes from dock-to-dock, to ensure those requirements are being met in line with the customer expectations and the regulatory requirements (FDA cGMP, BRCGS Consumer Products standard, ISO9001 standard).

Key Responsibilities/ Accountabilities

Process various documents supporting the Quality Management System (QMS), such as: Non-Conformance (NC) Reports, Corrective and Preventive Actions (CPAs), Deviations/Waivers, Customer Complaints and Quality Alerts. 

Use Root Cause Analysis to investigate and identify the true cause of NC product or processes, audit findings, etc. Based on the root cause, work as a team with various departments to create an action plan to prevent reoccurrence of issues.

Work with customers for approvals of CPAs, Deviations/Waivers, etc when necessary.

Conduct document reviews of various controlled documents to ensure processes are accurately being followed and/or need to be updated to reflect the actual process.

Act as a liaison and knowledge reference between Quality and various departments (i.e. Compounding, Filling, etc), to ensure procedures and specifications of various customers are being followed to produce product right first time.

Create and implement effective Control Plans for assigned products/processes.

Generate and/or edit controlled documents to ensure manufacturing processes are being followed in accordance with customer specifications, regulatory requirements, and established validation parameters.

Assist in conducting Annual Product Reviews (APRs) of regulated/drug products.

Participant of the Risk Assessment Team

MARGINAL JOB DUTIES:

Provide support for external audits; process audit findings as requested by management.

Work with vendors on supplier quality issues as needed.

Conduct assigned process capability studies.

Work with customers to resolve discrepancies in specifications, processes, etc to ensure both parties are in agreement.

Assist in planning, executing, and managing of process validations (for Cleaning, Sanitizing, Compounding, Filling, etc.) following IQ/OQ/PQ format for regulated/drug products. 

Work with customers as a cross-functional team to create peer reviewed validation protocols and reports.

Perform other duties as required or requested by management.

Education / Certification / Qualifications / Experience

• Minimum of Associate degree in Quality with a BA/BS degree in a field of science preferred or equivalent experience
• Lean Manufacturing and/or Six Sigma Green Belt preferred
• Background in manufacturing, with cGMP and FDA compliance preferred
• Proficient in Microsoft Word, Excel, and Outlook
  
  

LICENSE OR CERTIFICATION REQUIRED:

• None.
  
  

 

Specific Knowledge: (Technical/Product, Organizational and Interpersonal)

• Stand 10% of the time

• Walk 10% of the time
• Sit 80% of the time
• Use hands to finger, handle or touch 100% of the time

• Reach above shoulders less than 10% of the time

• Climb or balance less than 10% of the time
• Talk or hear 70% of the time
• Taste or smell up to 10% of the time
• Lift up to 25 pounds up to 5% of the time
• Close Vision (clear vision at 20 inches or less)
• Color Vision (ability to identify and distinguish colors)
• Ability to Adjust Focus (ability to adjust the eye to bring an object into sharp focus)
  
  

TOOLS/EQUIPMENT USED:

• Use the Computer up to 85% of the time.
• Use the Copier less than 5% of the time.
• Use the Telephone up to 10% of the time.
• Use Lab Equipment up to 5% of the time.
  
  

WORK ENVIRONMENT/PPE REQUIRED:

• Work near moving mechanical parts less than 5% of the time.
• Work in high, precarious places less than 5% of the time.
• Exposed to fumes or airborne particles up to 10% of the time.
• Risk of electrical shock less than 5% of the time.
• Work/job related travel less than 5% of the time.
• Moderate Noise.