Job description

Responsibilities:

•Design/Change Control - Responsibilities include participating in the development & review of all design input, risk management, design verification, design validation and design output/transfer related design change activity.

•Risk Management – Understands and applies basic Risk Management principles. Participates in the development and/or modification of Risk Management Files, FMEA’s, etc.

•Design Verification/Validation – Understands and applies basic Design Verification/Validation methods & principles. Participates in the development, modification and design review of Protocols, Data Summaries & Records.

•Documentation - Reviews documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity. Plans and performs assignments with a wide degree of difficulty.

•Quality System Compliance -Maintains awareness of standards that regulate our industry. Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.

•Quality Engineering – Participates on project teams and technical review boards. Coordinates quality decisions between different quality and engineering groups. Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products.

Apply quality principles, analyzes quality records, prepares reports and recommends improvements.

•Conduct inspection, verification and validation of components or materials used in development processes.

•Document quality issues and performance measures for management review.

Qualifications:

· Bachelor’s degree required

· Previous quality experience

· Previous knowledge of GMP regulations and standards affecting pharmaceutical products is preferred.

· Computer skills proficiency including word processing, spreadsheets, instrumentation related network systems

· Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11 preferred

Collaborative Technologies is proud to be an Equal Opportunity Employer.

Job Types: Full-time, Contract

Pay: $30.00 per hour

Benefits:

• Health insurance

Experience level:

• 10 years
• 11+ years
• 1 year
• 2 years
• 3 years
• 4 years
• 5 years
• 6 years
• 7 years
• 8 years
• 9 years
• No experience needed
• Under 1 year

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Overtime

Ability to commute/relocate:

• North Chicago, IL: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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