Associate Quality Engineer

Job Duties

Associate Quality Engineer

Location:

Minneapolis, MN, US

Job Family:

Quality Assurance

Country/Region:

United States

The Interventional Urology Operations Associate Quality Engineer is responsible for supporting and maintaining quality compliance within US Operations. In all actions, they will demonstrate a primary commitment to patient safety and product quality.

Major Areas of Accountability

Provide Quality Engineering support to US Operations to ensure FDA/ISO compliance and act as first line support for quality issues

Quarantine and disposition non-conforming product

Initiate and own non-conformances, including root cause analysis

Participate in Material Review Board (MRB) meetings

Participate in or lead Corrective and Preventive Actions as appropriate

Assist in preparing, reviewing and approving quality documentation, including SOPs and work instructions

Initiate and support Change Controls to update documentation and processes

Support complaint investigations

Identify and justify opportunities for quality and continuous improvement activities

Perform data analysis, write summary reports and other technical memoranda

Maintain applicable QMS instructions

Conform with Coloplast Code of Conduct and all local Compliance Standards

Conform with Coloplast Q/EHS Policy

Other duties as assigned.

Basic Qualifications

Bachelor's degree in engineering or related field

0-2+ years of related manufacturing or relevant work experience

Self-motivated and self-managed within a dynamic and collaborative team environment

Strong analytical and problem-solving skills

High performing individual that is able to accept challenges and opportunities as they arise.

Required Knowledge, Skills and Abilities

Ability to work independently and with general direction

Excellent written & oral communication skills, strong technical writing skills

Computer skills - Microsoft Office Suite (Access, Word, Excel, PowerPoint)

Strong decision-making skills

Strong problems solving and trouble shooting skills

Curious and eager to learn in a fast-paced, regulated industry

Ability to effectively interact with various internal and external customers/ vendors

Ability to convey a positive and professional image to internal and external customers

Ability to multi-task and prioritize multiple projects

Ability to communicate and train cross functionally at every level of the business

Understanding of FDA, QSMR, ISO 13485 and ISO 14971 requirements.

At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Here is some of what you can expect:

Health and Wellness:Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to company sponsored wellness programs and mental health resources, paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.

Financial Security:A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.

Work-Life Balance:Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.

Professional Development:Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.

Recognition and Rewards:Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.

Community and Culture:A supportive work environment where everyone feels valued, and has a sense of belonging. Participate in team-building activities, volunteer opportunities, and company-sponsored events. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.

Competitive Compensation: The compensation range for this position is $73,767 - $110,650. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 people and with products available in more than 143 countries, we are one of the worlds leading medical device companies. We are constantly growing our business and always looking for new ways to move forward - we explore, learn and look for new ways of doing things.

Visit us onColoplast.com.

Watch the film.Follow us onLinkedIn.

Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

62152

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Nearest Major Market: Minneapolis

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Minimum Education Required

Bachelor Degree

Minimum Experience Required

None

Shift

First (Day)

Number of Openings

1

Public Transportation Accessible

Yes

Veterans Encouraged to Apply

No

Physical Required

Yes

Drug Test Required

Yes

Compensation

$11.41 / Hourly

Postal Code

55411

Job Type

Full Time

Place of Work

On-site

Requisition ID

62152

Job Benefits

Not specified