Product/Process Quality Engineer

Overview

When you become part of the Demant family, you also become part of our quest to make a life-changing difference for over 500 million people all over the world who suffer from hearing loss.

Working with us, you will be part of a world-leading hearing healthcare group that develops, manufactures, and sells highly advanced, market-leading hearing solutions, diagnostic equipment, and personal communication.

Product / Process Quality Engineer is dedicated to ensuring that Demant's products, processes, and services consistently surpass customer expectations.

As a vital member of the quality team, Quality Engineer shall contribute to creating innovative solutions, identifying quality defects, conducting root cause analysis, and proposing effective solutions.

This role often collaborates with cross-functional teams, both locally and globally. Additionally, close collaboration with the commercial team is maintained to address product quality complaints, conduct analysis, and continually enhance the overall customer experience.

Candidate will be required to work on site 5 days a week in Somerset, NJ.

Responsibilities

Supporting, Reviewing, and approving processes :

• Monitors manufacturing process verifications to ensure compliance with operating procedures and specifications.
• Coordinating product recalls and non-conforming material withdrawal
• Conducting PFMEA on processes, changes to processes and ensure controls are in place. Chair PFMEA meetings and maintain PFMEA documentation.
• Conducting Leading projects and improvement tasks regarding process optimization.
• Participation in projects
• Coordinating activities implemented to solve quality problems.

Acting as CAPA and NCR responsible for areas of operations quality.

• Collaborating with other departments.
• Determine quality improvement factors.
• Actively coordinate and be responsible for new product launch activities as assigned to ensure flawless launch.
• Provide manufacturing floor support relative to process troubleshooting.
• Improve quality processes focusing on customer satisfaction using quality tools.
• Develop and integrate the use of SPC to eliminate process variation.
• Perform process validation as required and maintain documentation.

Product Quality : Troubleshooting product, Data analysis, trends, and reporting :

• Working with non-compliant materials and quarantine supervision.
• Approving new products and transfers.
• Provides support for quality investigations and resolution of quality issues.
• Report to management on quality issues, trends, and losses.
• Work cross functional with in market Product Support and US Marketing Team
• Interface with supplier and customer quality representatives concerning problems with supplier quality issues and assure effective corrective action implementation.
• Monitors and evaluates current testing processes, making recommendations for improvements when necessary.
• Conducts visual and physical inspections of company products and materials.
• Analyzing and displaying trends for key parameters of product complaints (ARC, IRL. Service, QC).
• Identifying, defining, and reporting of key problems from the business point of view (Wholesale Teams).
• Testing hearing aids (QSP, ARCs, Service and QC Complaints).
• Communicate effectively with internal stakeholders regarding quality issues and recommend solutions. Chair change notification meeting, verify implementation and close out in a timely manner.
• Develop cost of quality data, analyze, recommend, and implement process improvements.

What we have to offer

Medical, dental, prescription, and vision benefits (including coverage for domestic partners)

24 / 7 virtual medical care

Employee Assistance Program for you and your family

401(k) with company match

Company-paid life insurance

Supplemental insurance for yourself, your spouse / partner, and your children

Short-term and long-term disability insurance

Pre-tax Health Savings Account and Flexible Spending Accounts for Health Care or Dependent Care

Pet Insurance

Commuter accounts

Let us find you! Apply now.

The Company is an Equal Opportunity / Affirmative Action employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.

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Qualifications

• Bachelor’s degree in engineering, Quality or equivalent discipline is required. ASQ CQE certification preferred but not essential.
• A minimum of 2 years’ experience in a technical or quality position required in manufacturing environment. Experience working in medical device industry preferred.
• Knowledge of ISO13485 : 2016 & MDSAP is desirable. Exposure to FDA quality system regulation is an asset.
• Knowledge of process validation, risk management & process PFMEA is a must.
• Possess a strong understanding of core process methodologies and problem-solving techniques.
• Strong communication skills - written and verbal.
• Detail oriented, critical thinker and excellent organizational skills.
• Ability to work under pressure in a fast paced and demanding environment.
• Computer skills : Excel, Visio, power point

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