Quality Compliance Manager

**Essential Job Functions**
- Establish Quality Operations and Quality Control function at station, including assisting in hiring, developing, and conducting training.
- Conduct weekly reviews to ensure quality is being maintained and review with Operations Manager.
- Determine process validation and maintenance of controlled environment/storage requirements.
- This process to be documented and retained based on good documentation processes as established
- Partner with relevant internal and external teams to ensure products are stored in compliance with regulatory requirements. To be reviewed weekly.
- Develop and improve product assurance systems such as process deviations, product/process changes, statistical analyses, root cause investigation, incoming and in-process quality assurance, product monitoring and final product release, including establishment of metrics for these areas. Reviewed with Operations Management on a weekly basis.
- Review/approve inspection plans and methods to ensure thorough and efficient inspection processes and to ensure those inspections are commensurate with the associated level of risk.
- Escalate to Operations Management as needed to achieve root cause corrective action.
- Develops and analyzes reports to monitor and evaluate quality performance in meeting established goals related to the quality management work plan and contractual requirements.
- Coordinates guidelines, studies, and performance improvement activities in concert with the utilization management, quality management, pharmacy services, case management and device management programs.
- Assists in the tracking and monitoring of systems for quality improvement activities according to regulatory requirements, policies and procedures, and contractual agreements.
- Monitors productivity of department staff and establishes productivity minimum expectations for each role. Provides regular feedback and support to staff in meeting performance expectations.
- Prepares, compiles, reviews, and submits monthly and quarterly reports for the Quality/Programs Committee, Compliance Committee meetings, and Department monthly report.
- Review/approve proposed changes and their impact on product, processes and safety.
- Identify problems, and propose resolutions that are timely, cost-effective, and meet quality requirements.
- All other duties as assigned.

**Other Skills & Abilities**
- In-depth knowledge of quality control procedures, sampling procedures and sampling methods
- In-depth knowledge of the interactions/interfaces between Risk Management, Quality Engineering and Quality Control processes
- In-depth knowledge of test method validations, failure analysis, statistical methods
- Strong working knowledge of quality tools, including measurement repeatability systems and process control tools
- Strong analytical problem-solving skills
- Ability to investigate complex issues using proven tools/methods, develop potential solutions, and implement fixes
- Demonstrated team leadership and development skills including training of functional personnel to applicable standards and career planning for team members

**Physical Requirements**
- Job may require extended sitting or standing, use of standard office equipment.

**Education & Experience**
- Bachelor of Science degree in Engineering or related discipline preferred
- 5 years of supervisory experience
- Working knowledge of ISO Standards (ISO 9001, ISO13485 and FDA 21 CFR 820) for the manufacture of medical devices

**CERTIFICATIONS AND LICENSES**
- Professional certification may be required in some areas.

**MUST COMPLETE PI ASSESSMENT IN ORDER TO BE CONSIDERED FOR THE POSITION**:
**WHY SHOULD YOU WORK FOR CRANE?**

At Crane, we believe in providing our employees with excellent benefits at a Great Place to Work.

We offer:

- 136 hours of Paid Time Off which equals 17 days for the year, that can be used for Sick Time or for Personal Use
- Excellent Medical, Dental and Vision benefits
- Tuition Reimbursement for education related to your job
- Employee Referral Bonuses
- Employee Recognition and Rewards Program
- Paid Volunteer Time to support a cause that is close to your heart and contributes to our communities
- Employee Discounts
- Wellness Incentives that can go up to $100 per year for completing challenges, in addition to a discount on contribution rates
- Potential to earn a strong commission based on your sales ability

Come join the leader in logistics and take your career in the right direction.

**Disclaimer**:
The above statements are intended to describe the general nature and level of work being performed by people assigned to this position. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

The physical demands described here are representative of those that must