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.
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.
- Conduct PFMEA on processes, changes to processes and ensure controls are in place. Chair PFMEA meetings and maintain PFMEA documentation.
- Perform risk management on every process as required and suggest mitigation plan.
- Conduct Leading projects and improvement tasks – regarding process optimization.
- Participate in projects, coordinating activities implemented to solve quality problems.
- Act as CAPA and NCR responsible for areas of operations quality.
- Collaborate with other departments to resolve quality, process issues.
- Determine quality improvement factors, recommend & implement.
- 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 Process Quality: Troubleshooting product, Data analysis, trends reporting:
- Work with non-compliant materials and quarantine supervision.
- Provide support for quality investigations and resolution of quality issues.
- Maintain & keep up-to-date data analysis, trend charts spreadsheet and present report to the management on quality issues, trends etc.
- 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.
- Monitor and evaluate current testing processes, making recommendations for improvements when necessary.
- Conduct visual and physical inspections of company products and materials.
- Analyze and display trends for key parameters of product and process complaints (ARC, IRL. Service, QC).
- Identify, define, and report of key problems from a business point of view.
- Test hearing aids from QSP, ARCs, Service and QC Complaints & file QC complaints in QC system.
- Review potential health & safety risk cases, investigate and file PHSR cases in quality complaint system as per operating procedures.
- Communicate effectively with internal stakeholders regarding quality issues and recommend solutions.
- Chair change notification meeting, verify implementation and close out in a timely manner.
- May perform miscellaneous tasks/projects as directed by manager.
Qualifications:
- Bachelor’s degree in engineering, Quality or equivalent discipline is required. ASQ CQE certification is 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
What we have to offer:
Medical, dental, prescription, and vision benefits
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
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.
The pay range for this position is expected to be between $67,200 to $96,000 per year; however, while the salary range is effective as of the date of this posting, fluctuations in the job market may necessitate adjustments to pay ranges. Further, final pay determinations will depend on various factors, including but not limited to experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, such as bonus, commissions, or discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
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