Engineer, Quality Complaint Investigation (CAPA) Hybrid
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Job Location:
Skaneateles, NY - USA
Monthly Salary:
Not Disclosed
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
For further inquiries about this opportunity please contact one of our Talent Specialists Hema at or Sri Balan at
Title - Engineer Quality Complaint Investigation (CAPA) - Hybrid
Duration: 9 Months
Location: Hybrid at Skaneateles NY
Duration: 9 Months
Location: Hybrid at Skaneateles NY
Local candidates preferred
Will consider relocation candidates
Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.
Description:
I. SUMMARY:
This description outlines the employment prerequisites and job responsibilities for the position of Engineer Quality Complaint Investigation.
II. ESSENTIAL FUNCTIONS:
This position has primary responsibility for investigation review and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs.
Review individual complaints and associated service data to determine risk level and complete investigation into the as determined problem code and cause codes for each complaint.
Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA) Complaints FDA Medical Device Reports (MDR) etc.) to determine trends and systemic issues. Prepare and issue reports based on information analysis.
Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.
Develop and communicate expectations for quality performance continuous improvement and process controls for marketed products.
Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations conducting data analysis and implementing corrective actions.
Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
Support CAPA and maintenance activities for existing product lines.
Recommend and/or support projects for improvements to the quality system as approved by management.
III. QUALIFICATIONS KNOWLEDGE AND SKILLS REQUIRED
Medical Device Experience with knowledge of 21CFR820 preferred.
Investigational research skills
Experience with any statistical software packages (Minitab a plus)
Desired experience in the medical device industry in the development and deployment of Quality Systems process controls and continuous improvement methods.
Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC requirements; CMDAS (optional).
Knowledge and working application of reading and understanding blueprints and technical drawings.
Demonstrated strong analytical problem-solving (Root Cause Investigations.
Display a solid technical understanding of engineering principles and procedures (e.g. CAD and its application or scheduling a series of technical tasks utilizing software-based tools).
Computer competency in Word Excel PowerPoint Minitab Access and databases.
Ability to multitask and methodically manage projects.
IV. EDUCATION/EXPERIENCE REQUIRED
A Bachelor of Science degree in Engineering
1-3 years of Medical Device experience
V. PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job the employee:
Must be able to sit for long periods of time
Must have good hand-to-eye coordination and dexterity
Physical Requirements: Dynamic Lifting capability: Must have the ability to lift 40 pounds at a time.
VI. WORK ENVIRONMENT
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to:
Wearing a static protective smock at all times while in the work area
Wearing a ground wrist strap and plugging that wrist strap into the working table.
Working in proximity to other employees.
Working in an environment that is temperature and humidity-controlled.
This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to:
Wearing a static protective smock at all times while in the work area
Wearing a ground wrist strap and plugging that wrist strap into the working table.
Working in proximity to other employees.
Working in an environment that is temperature and humidity-controlled.
Responsibilities:
Will be addressing customer complaints and leading complaints investigation.
Identify RCA.
Identify RCA.
Collaborates with the Engineer Product service teams and follow-up on service updates.
Quality experience is preferred 2 years would be ideal.
Good to have experience in technical writing and handling class ii medical device.
Will be writing customer feedback letter addressing customer issues and root-cause findings.
Will support the functions of NCQ CAPA Audit.
Current team has 2 perm 3 contract backfill will be for the 3rd.
Getting about 1000 complaints a month want to keep it less than 100 actions a week.
Looking for a good communicator who is good at follow-ups.
Proficiency with SAP ETQ Trackwise will be preferred.
Will be onsite for Team meeting addressing complaints once a month data trending warehouse visits when required.
Quality experience is preferred 2 years would be ideal.
Good to have experience in technical writing and handling class ii medical device.
Will be writing customer feedback letter addressing customer issues and root-cause findings.
Will support the functions of NCQ CAPA Audit.
Current team has 2 perm 3 contract backfill will be for the 3rd.
Getting about 1000 complaints a month want to keep it less than 100 actions a week.
Looking for a good communicator who is good at follow-ups.
Proficiency with SAP ETQ Trackwise will be preferred.
Will be onsite for Team meeting addressing complaints once a month data trending warehouse visits when required.
Education: Bachelors is a must have.
Interview: Remote/ virtual screening with final onsite interview.
About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.
Key Skills
- Food Safety
- Suspicious Activity
- Financial Crimes
- Administrative Hearings
- Ofac
- SAR
- Public Safety
- Law Enforcement
- Due Diligence
- AML
- Criminal History
- escalate
- Procedures
- Subpoenas
