Quality Lead Inspector
@ Freudenberg Medical LLCQuality Lead Inspector
About the job
Freudenberg Medical LLC is a global manufacturer in the medical device industry. The Quality Lead Inspector oversees inspection activities, trains staff, ensures compliance, and maintains quality standards to support manufacturing operations.
Requirements
- 8+ years in quality roles
- Knowledge of ISO 13485 and FDA 21 CFR
- Experience leading teams
- Proficiency with SAP and MasterControl
- Ability to work in cleanroom environments
Qualifications
- High school diploma or GED
- Strong leadership skills
- Good communication skills
- Ability to lift 50 lbs
- Experience with medical device regulations
Full job description
Working at Freudenberg: We will wow your world!
Responsibilities:
- Leads and directs the daily activities of all inspection functions within the Quality department & coordinate inspector’s workload.
- Maintain QC inspector timecards and approve payroll.
- Place purchase requests for QC operating supplies and office equipment.
- Train QC inspectors making sure standard work is being followed.
- Determine training targets, update and maintain versatility matrix.
- Applies sampling standards. Ensures team is cross-trained.
- Performs operational checks, preventative maintenance checks and accuracy verifications of measurement and test equipment used in production, Engineering and other areas.
- Oversee the inspection and testing of materials, parts and products to ensure adherence to established requirements and quality standards.
- Oversight of non-conforming materials and ensuring that product is properly segregated dispositioned per MRB.
- Tests and controls WIP, raw material and finished product quality, ensuring compliance with company standards and applicable government regulations.
- Interprets and executes inspection requirements according to company requirements.
- Responsible for scheduling quality inspection activities to support operations in meeting required schedules or to resolve complex problems.
- Analyzes and corrects issues with system performance, and identifies and drives system improvements.
Qualifications:
High school diploma or equivalent (GED).
At least 8 years in quality-related roles.
Comprehensive knowledge of medical device regulations and quality systems (e.g., ISO 13485, FDA 21 CFR Part 820).
Proven ability to lead teams, drive quality initiatives, and mentor inspectors on procedures, standards, and tools.
Strong leadership, coaching, and communication skills; ability to anticipate quality risks and implement preventive actions.
Experience with SAP and MasterControl systems to ensure data integrity and compliance.
Ability to stand for long periods, perform fine motor tasks, lift up to 50 lbs., and work in cleanroom environments.
The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.
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