Qa Specialist - Complaint Handling

About Us:
How many companies can say they've been in business for over 177 years?!
Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team!

What's the role?

To assist in maintaining Quality Assurance and Control practices in adherence to the Food and Drug Administration (FDA) regulations for the Quality System Regulation and for ISO 13485 standards, the QA Specialist is responsible for managing Complaint Handling, returned goods tracking and reporting requirements. The Quality Control Compliance Specialist will be responsible for working with the Engineering, Manufacturing and Quality Assurance teams coordinating activities required for investigations including failure analysis, nonconformance and CAPA related to complaints. The position requires reporting returns to regulatory agencies as required and close investigations within appropriate timeframes.

Sounds Interesting?

Here's what you'll do:

• Evaluate, investigate, and resolve complaints while also analyzing complaint data and gathering additional information as needed.
• Manage the complaint investigation process end-to-end.
• Work with other teams in a collaborative environment to complete the end-to-end complaints process in a highly regulated environment.
• Document product return and/or complaints as well as the results of investigations in a timely manner.
• Interface with customers and internal employees for reporting of complaints and returned goods.
• Document the analyses of product complaints for trends and identification of potential corrective or preventive actions.
• Report product complaints to appropriate regulatory agencies as required.
• Serve as a member of the internal audit team and implement/assist in implementing corrective and preventive actions.
• Recommend improvements in quality system to ensure that the quality system is efficient and effective controls are in place to minimize risk.
• Complete projects in a timely manner and consistent with corporate objectives.

Do you qualify?

• H.S. Diploma with 3+ years relevant experience
• Bachelor's degree in engineering, clinical sciences, related sciences is preferred.
• 3+ year of post-market complaints experience in a medically regulated industry with an understanding of appropriate global medical device regulations, requirements, and standards such as ISO 13485 and FDA QSR.
• Medical Device and or other regulated industry (Pharma, IVD,) preferred.
• Must be able to work within a team to gather information needed to understand and solve problems
• 2+years' experience in Technical Writing
• 2+ years' experience with creation and writing procedures or policies
• Working knowledge of Microsoft software programs Word, Excel and PowerPoint, preferred Quality Management software knowledge preferred
• Ability to effectively communicate (written, reading or orally) with others within and outside the organization (i.e. management, supervisors, coworkers, inspectors and auditors from various governing bodies, such as FDA auditors).
• Ability to read and comprehend instructions, correspondence, and memos. Ability to effectively present information in one-on-one and small group situations to other employees of the organization. Bi-lingual a plus.
• Ability to add, subtract, multiply, and divide in all units of measures, using whole numbers, common fractions, and decimals.
• Ability to apply common sense understanding to carry out instructions. Ability to deal with and solve problems and be decisive.
• Basic computer skills are a plus. Energetic, self-motivating, team player, and can perform duties with minimal supervision.

Working Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this 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 is; occasionally exposed to fumes or airborne particles, moving mechanical parts and vibration.

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 this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Light to moderate physical effort required.

Must be able to regularly lift and /or move up to 5-15 pounds.

Regularly required to sit and walk

Repetitive use of hands; typing and simple grasping

We have amazing benefits to support you as an employee at ZEISS!

• Medical
• Vision
• Dental
• 401k Matching
• Employee Assistance Programs
• Vacation and sick pay
• The list goes on!

Position Type/Expected Hours of Work

This is a full-time position. Usual hours of work are Monday through Friday, 7:00 a.m. to 3:30 p.m., 40 hours per week, overtime may be required as needed.

The hourly pay range for this position is $30.00 -$37.00 .

The pay offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, & complexity/specialization/scarcity of talent.

This position is also eligible for a performance bonus. ZEISS also offers robust benefits, including medical plans, retirement savings plan and paid time off.

ZEISS is an EEO/AA/M/F/Disabled Veteran Employer

Your ZEISS Recruiting Team:
Christina Choing

Zeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends).