Quality Complaint Analyst 1 Jobs

Specialized Knowledge: Computer skills as required by stated accountabilities. Basic word-processing and spreadsheet skills. Problem solving skills.

Minimum Education: Bachelor’s degree in a related field

Minimum Experience: 0-3 years of experience

Special Skills: Strong written and oral communication skills. Ability to work in a team environment.

Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.

Performs work which involves conventional types of plans, investigations, surveys, structures, or equipment.

Maintain electronic quality management system/software for post-market surveillance to collect, monitor and trend data within areas of responsibility.

Analyze post-production data for compliance with U.S. and international regulations and requirements (ISO 13485, 14971, etc.).

Monitor assigned projects and tasks to ensure compliance with regulatory agencies, protocols, agreements, and applicable corporate compliance requirements.

Strong knowledge of quality system regulations (FDA QSR, ISO 13485).

Must possess good verbal and written communication skills with an investigative mindset and critical analysis skills.

Investigate product complaints and adverse events to determine root cause and the need for corrective action.

One to two years of relevant experience, preferably in quality analysis and measurement activities

Good knowledge and understanding of the products and services applicable to the assigned area

Good knowledge of the productivity and accuracy standards of the assigned area

Effective verbal and written communications skills

Proficient computer navigation skills using a variety of software packages including Microsoft Office applications

High school diploma or equivalent

Analyzes current processes and customer requirements to identify activities to improve efficiency, effectiveness and exceed customer expectations.

Develops expert knowledge of customer portals, processes and overall expectations in order to assist DENSO Plants to achieve customer satisfaction.

Bachelor's Degree in manufacturing, industrial or process engineering or related field, or a combination of work and education

Responsible to lead/guide Quality Resident Engineers for non-local customer assembly plants.

Monitors, analyzes, tracks and disseminates quality performance indices to appropriate areas throughout organization.

Health, Dental, Vision, Prescription Drug plans

Compile monthly grants management report which detail outstanding grants management items for each program

Gather program data, outputs, outcomes to track performance metrics and success stories for all RD programs

Perform other job-related duties as assigned

Demonstrates planning, organizational, and time-management skills with the ability to multitask and prioritize own work.

Works with field management to ensure the protection of finished work.

Tradesperson or bachelor’s degree in engineering, construction management, or a related discipline.

Reviews prime contract and subcontract details for specifications and requirements.

Reviews the project specifications and identifies quality requirements.

Identifies and discerns root causes associated with nonconformances and reports to the project team and quality manager.

Strong organization, speaking skills, and influential management ability.

Provide diligent and fact-based communication to Executive Management team, peers, and team.

Provide management and development of the Quality staff.

Bachelor’s Degree in a related field or an equivalent combination of education and work experience

Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies.

Manages relationships with external vendors, contractors or suppliers to ensure that their products or services meet the organization's quality standards.

Higher in range - Experience and skills add value above typical requirements of the role

Lower in range - Building skills and experience in the role

Mid-range - Experience and skills align with proficiency in the role

Assess the quality of the loan files following pre-determined post-funding, accounting and collateral requirements

Bachelor’s Degree or higher in Business Administration, Finance or related field, preferably in Accounting

General knowledge of accounting, the mortgage industry and operational practices

Bachelor's degree in Engineering or equivalent combination of education and experience in related field

Informs management of problem status and resolution progress

3-years quality related experience in automotive production

Excellent verbal, written, and interpersonal communication skills

Knowledge of automotive glass and glass lamination process preferred

Acquire and maintain product certification

Manage the timely in-flow of customer complaints, the assignment of investigation responsibilities, and expedient processing and closure.

Manages complaints associated with multiple manufacturing sites.

Manages calibration due dates to ensure equipment does not become overdue.

Perform complaint analysis and summarize complaint investigation.

Work closely with investigators to ensure thorough and accurate investigations and drive the initiation of CAPAs when appropriate.

Coordinate the communication of investigation data to corresponding divisions as applicable.

• Generates Monthly and Quarterly Metrics for periodic Quality Management reviews and presentations.

• Monitors complaints for product trends and notifies Manager of events requiring immediate action.

• Complaints processing experience is preferred

Clinical Product Quality Complaints and Systems role:

• Reviews vendor investigations and completes TrackWise.

• Leads protocol specific PQC call center training and PQC training of the clinical site

Must possess basic computer skills; knowledge of word processing and spreadsheet programs required.

Knowledge of Good Manufacturing Practices.

Experience using Lab equipment including: CEM, FT120, D-Count, Epic, Petrifilm, Lateral Flow Device, pipettors,

Must possess strong oral and written communication skills.

Must have decision-making abilities to determine best course of action in assessing test results.

Must be able to work with chemicals.

Manage calibration recordkeeping and update records on system.

Operate lab equipment and gages properly and adhere to all safety requirements in the work area.

Maintain receiving files and records per requirements.

Operate tools, and equipment properly and adhere to all safety requirements in

Maintain files and records per requirements.

Operate tools, presses and equipment properly and adhere to all safety requirements in the work area.

Assist with field sample management process for products returned from Consumer.

Prepare and present Complaint Vigilance data to QA Management, PMS partners and business partners.

Proven knowledge and expertise in quality processes and regulatory requirements.

Minimum 4 years of relevant work experience.

Quality Assurance and/or Quality Control experience.

Experience working in pharmaceutical, medical devices, a health authority regulated environment or other related or highly regulated industry.

Knowledge and application of computer systems for word processing and complaint management.

Identification of potentially reportable events and notification to appropriate functional groups and management.

Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.

Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.

Assure complaint records meet global requirements.

This requires good analytical skills, technical writing and good documentation.

Organizational skills and knowledge-based PC computer skills essential, such as industry recognized complaint management systems, MS Access and Excel.

Perform other function-related activities in addition to the above-mentioned responsibilities as reasonably required by business needs.

General skill with technical information, use of a computer, and problem solving/analysis

Experience in an Operations/GMP environment desirable

Good technical writing skills and ability to communicate technical information

Experience in the healthcare/device industry or exposure to medical device quality system regulations is preferred.