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Sr Quality Engineer - Post Market at Kimberly-Clark Corporation

Posted in General Business 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: neenah, Wisconsin





Job Description:

Sr Quality Engineer - Post Market

Job Description

Sr Quality Engineer - Post Market

Neenah, WI

Position Purpose:

Provides Quality/Regulatory and Medical Professional/Technical support for assigned quality systems, executing systems transactional work, routinely checking for compliance with standards, and providing limited training.

Customers:

Operations, Corporate Quality Assurance, Regulatory Affairs, Product Safety, Research & Engineering, Packaging, Legal, Marketing, Contract Manufacturers, Consumer Services, Clinical Affairs, Regulatory Agencies, Consultants.

General Expectations and Accountabilities:


  • Demonstrate safety as a value by performing all job functions safely, while also complying with corporate policies and departmental procedures, in an effort to reduce risk and eliminate loss.

  • Manages self in accordance with the expected behaviors of the Leadership Qualities. Effectively achieve results that meet business and individual objectives.

  • Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations, such as GMPs and ISO requirements.

  • Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed, as applicable.

  • Performs production and quality systems audits.

  • Maintain and demonstrate an appropriate level of knowledge and skill in product forms, quality systems, processes, and regulations.

  • Establish and maintain good customer rapport, while driving solutions to meet business needs. Develop and maintain a strong spirit of partnership.

  • Conduct all communications and transactions with the utmost integrity. Communicate fully with superiors, teammates, and others who have a need to know.

  • Executes continuous improvement activities for established processes and initiates/supports development of new processes.

  • Builds and maintains capability in QMS, ISO, and GMPs to support objectives.

  • Work results have the ability to influence longer-term product or functional decisions.

  • Requires independent completion of work, where judgment and discretion is required within the boundaries of the Post Market Surveillance end to end process

Position Specific Accountabilities:


  • Provide medical insight into the Complaint Handling Processes, end to end. Lead PMST activities to ensure the complaint handling process is consistently applied and compliant to internal and external regulations.

  • Reports and discusses trends in product/process categories with Quality Assurance, Regulatory Affairs, & Research & Engineering team members/leaders.

  • Manage Change Control activities related to the Complaint Handling System(s)

  • Execute assigned Post-Market Surveillance activities, including Complaint Assessment, Investigation, Trending/Reporting, Decision Tree Completion, Final Review, and Sample Evaluation. Flow to Work to assist others as needed.

  • Act as the owner of one or more quality sub-systems (within Post-Market Surveillance), making recommendations and decisions on changes to standards, providing training to users, and supporting implementation as needed.

  • Identifies need for, develops, and executes continuous improvement plans for the assigned sub-system(s) to deliver business results.

  • Builds and maintains capability within the assigned sub-system for compliance with QMS, ISO, and FDA GMP's.

  • Responsible for providing Post-Market Surveillance support to assigned Mills and/or Product Forms via Standard Work, data analysis, and communication. Responsible for completing Level 1 & 2 Complaint Investigations on behalf of Mills.

  • Initiates and follows up on CAPA and QNC related to the assigned system(s)

  • Provide medical insight to assigned brands as well as supporting team requirements for preliminary medical assessment. Align opinions with Product Safety and Senior Medical Officer and escalate as needed.

  • Provide quality engineering support for other assigned Quality/Safety/Compliance tasks, as needed.

Scope

This position reports to SR. Quality Manager – Post-Market Surveillance & Consumer Services. Has responsibility for execution of and record-keeping for quality systems in support of regulated products, with an emphasis on evaluating complaints using medical technical knowledge and escalating/communicating accordingly. Has responsibility for continuous improvement of quality sub-systems in support of regulated products and leads small to moderate-sized improvement projects. Plans and carries out routine workload and small system improvement projects with minimal direction but asks for assistance/guidance when appropriate.

Qualifications/Education/Experience Required:


  • Requires a Bachelor’s degree in nursing or related medical discipline or 7-9 years broad experience in a medical function.

  • Incumbent should have experience influencing multi-functional teams.

  • Knowledge of Medical Device requirements is desired.

  • Work results have the ability to influence longer-term product or functional decisions.

  • Requires independent completion of work, where judgment and discretion is required within the boundaries of the Post Market Surveillance end to end process

Dimensions:

Operating Budget: Indeterminate

Personnel: Can provide work direction for 0-5 people, depending on role, objective, or project - at manager discretion

Travel Expectations:

Position may require travel of up to 10% to support business requirements

Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 175 countries. Every day, 1.3 billion people - nearly a quarter of the world's population - trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or No. 2 share positions in more than 80 countries. With more than 140 years of history of innovation, we believe in recruiting the best people and empowering them do their best work.  If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark. 

Kimberly-Clark is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity, age, pregnancy, genetic information, citizenship status, or any other characteristic protected by law. 

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

This position may require a post-offer/pre-hire Physical Abilities Test (PAT) to confirm that individuals are able to perform the essential functions of the job.

K-C requires that an employee have authorization to work in the country in which the role is based.  In the event an applicant does not have current work authorization, K-C will determine, in its sole discretion, whether to sponsor an individual for work authorization.  However, based on immigration requirements, not all roles are suitable for sponsorship. This position is subject to drug and alcohol testing, including pre-employment testing.

Global VISA and Relocation Specifications:

K-C will support in-country relocation for the chosen candidate for the role, including assistance to obtain proper work authorization. The benefits provided will be per the terms of K-C’s applicable mobility policies. The benefits/policy provided will decided in K-C’s sole discretion.

This position is subject to drug and alcohol testing, including pre-employment testing.

Primary Location

USA-WI-Neenah

Additional Locations

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time