This position acts as a primary contact for receiving, processing, trending and reporting product complaints. Maintains the problem log to record and identify recurring issues and report these to Manager, International Complaint Handling. Processes, investigates, documents and monitors trending and reporting of product defect complaints assigned in accordance with company guidelines and external regulatory requirements for the handling of customer complaints as mandated by the FDA.

This includes; recording, reviewing and approving incoming complaints, assigning investigation responsibility, conducting investigations and reporting problems to applicable manufacturers, identifying trends, etc. May collaborate with other internal groups to respond to product inquiries and issues. May directly answer telephone, email or written inquiries regarding complaints.

II. Minimum Knowledge, Education and Skill Requirements

Required

Minimum years of relevant work experience:

1-2 years of related Quality or Complaint handling experience; or equivalent work experience

Minimum education, certifications and/or credentials:

A minimum education level of High School Diploma
Minimum hard skill requirements (including computer and application proficiency):
Knowledge of SAP transactions relating to complaints and product information
Ability to be pro-active.
Must be familiar with Word, PowerPoint, and Excel
Must be able to work both independently and as part of a team.
Excellent verbal and written communication skills and interpersonal skills
Minimum soft skill requirements:
Ability to exercise discretion and confidentiality with sensitive patient/company information.
Ability to grasp concepts and be a quick study.
Ability to organize and focus on completion of tasks in a timely manner.
Ability to build Internal/External customer relationships.
Strong computer and organizational skills

Preferred

Preferred years of relevant work experience:

1-2 years of related Quality or Complaint handling experience

Preferred education, certifications and/or credentials:

Bachelor’s degree and a minimum of 2 years of related experience

Preferred hard skill requirements:

Problem solving skills.
Knowledge of Quality Management Systems
Knowledge of SAP transactions
Knowledge of FDA and ISO Regulations, Complaint Handling Guidelines, GMPs, and/or familiarity with standard operating procedures

Preferred soft skill requirements:

Participate in internal or external audits.
K ARL STORZ product knowledge

III. Essential Functions

Must be able to maintain productive working relationships, treat fellow employees with respect. Possess high ethical standards.
Has contact with: Director, Product Liability; International Complaint handling; Marketing and internal and external KS customers in North America.
Manages assigned complaints, conducts investigation, enters evaluation codes and closes complaints in a timely manner.
Apply company policies and procedures to resolve a variety of issues.
Develop knowledge on product specialties assigned.
Create trending reports.
Provide and assist with incoming complaint requests.
Exercises judgment within defined procedures and practices to determine appropriate action(s).
Interacts with other departments, as directed, to complete assigned tasks.
Tracking and preparing complaint specific information utilizing databases, spreadsheets, and other tools.
Under close supervision, reviews and participates in the quality assurance of complaint data or documents.
Investigational duties include the ability to locate technical information and utilize appropriate resources, e.g., Marketing, R&D, Tech Support, Manufacturer, Sales Force, FSTs, OES’s, and customer, to properly investigate complaints.
Physical requirement/Demands: Ability to multitask efficiently, complete tasks on time, and handle deadlines under pressure.

Interpersonal and communication skills:

Builds productive internal/external working relationships.
Continuously contribute to process improvements
Works on problems of moderate scope

#LI-CW1

Your Benefits

Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!*
3 weeks vacation, 11 holidays plus paid sick time*
Up to 8 weeks of 100% paid company parental leave**
401(k) retirement savings plan providing a match of 60% of the employee’s first 6% contribution (up to IRS limits)
Section 125 Flexible Spending Accounts
Life, STD, LTD & LTC Insurance
We prepay your tuition up to $5,250 per year! – Tuition pre-imbursement
Fitness reimbursement of up to $200 annually
Employee referral program of up to $2,000 per hire
And much more!

Once in a while baby sister with experience with autistic kids.

In India, there are various benefits and guidelines that govern the employment landscape. Here are a few not unusual aspects associated with task advantages for employees in India:

Provident Fund (PF): The employees’ Provident Fund (EPF) is a obligatory financial savings scheme for employees. Both the business enterprise and employee make a contribution a percentage of the worker’s income to the EPF. The accumulated amount may be withdrawn upon retirement or resignation.

Gratuity: Gratuity is a lump sum charge made by employers to employees as a token of appreciation for his or her years of provider. It is relevant to employees who have finished at least 5 years of continuous provider with the equal organisation.

Health insurance: Many employers offer health insurance or clinical blessings to personnel. This will cover hospitalization charges for the employee and occasionally for their dependents.

Depart rules: employees in India are entitled to diverse types of leaves, inclusive of earned or paid leave, unwell go away, and informal depart. Maternity and paternity go away also are supplied as in keeping with statutory guidelines.

Employee state coverage (ESI): ESI is a social protection and medical insurance scheme for employees. It provides scientific and cash benefits to employees and their households in case of sickness, maternity, or employment harm.

Country wide Pension device (NPS): some employers offer the country wide Pension machine, a voluntary lengthy-time period retirement savings scheme designed to permit systematic savings for people.

Paintings Hours and overtime: the standard workweek in India is normally 48 hours, unfold over six days. Beyond regular time is paid for paintings performed past the standard hours.

Maternity and Paternity leave: Maternity go away is mandated with the aid of regulation, offering lady employees with paid depart earlier than and after childbirth. Paternity depart is also becoming extra not unusual, although it isn’t mandated via law.

Bonus: Employers may also provide annual bonuses to employees, frequently round competition times. This is mostly a percentage of the worker’s annual earnings.

Worker inventory alternatives (ESOPs): In some sectors, in particular in IT and startups, employees may be supplied stock options as a part of their compensation package.

Training and education: some agencies help the ongoing education and education of their employees through imparting financial help or examine depart.