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Date: Mar 16, 2023
Location: Plymouth, MN, US, 55113
Company: Evoqua
About Evoqua Water Technologies
Evoqua Water Technologies is a leading provider of mission critical water and wastewater treatment solutions, offering a broad portfolio of products, services and expertise to support industrial, municipal and recreational customers who value water. Evoqua has worked to protect water, the environment and its employees for more than 100 years, earning a reputation for quality, safety and reliability around the world. Headquartered in Pittsburgh, Pennsylvania, the company operates in more than 160 locations across ten countries. Serving more than 38,000 customers and 200,000 installations worldwide.
Apply today to join our 4000 professionals around the world as we pursue our purpose: Transforming Water. Enriching Life.
At Evoqua, we are committed to fostering and maintaining an inclusive and diverse workplace where employees can be their authentic selves. If this position interests you and you possess the minimum qualifications, we encourage you to apply as you could be the right fit for this or other roles we are looking to fill. Evoqua encourages all candidates meeting the minimum qualifications/requirements for the position to apply.
Position Summary
We are currently looking for a Senior Product Compliance Analyst for our location in Plymouth, MN or to work remotely in the US. In this role, you will ensure that company functions align with US Government and Medical Device compliance standards. You will also collaborate with operations and functional groups to ensure that all processes and procedures are aligned with compliance standards.
What we can offer you
Our Total Rewards Program goes far beyond base compensation by providing a more fulfilling work experience and offering a competitive benefits program, including:
- Health, dental, and vision insurance
- Unlimited PTO
- Fertility benefits, adoption assistance, parental leave, and pet insurance
- Generous retirement savings and profit-sharing plan
- Employee wellness program
- Rewards and recognition program
Core Responsibilities and Tasks
- Support maintenance of regulatory compliance within US Federal Government and Medical Device business areas
- Deliver regulatory and quality objectives by collaboration with related operations/functional groups through implementation of regulatory and ISO standards
- Create and maintain standard operating procedures and recommend changes to company procedures in response to changes in regulations
- Interpret regulatory rules / changes and business objectives and ensure that they are communicated through corporate policies and procedures
- Work directly with the Manager of Product Compliance and coordinate efforts associated with the preparation of regulatory documents or submissions and communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review
- Analyze product complaints and make recommendations regarding their reportability and corrective actions directly to the Manager of Product of Compliance
- Participate in new product development activities to define premarket regulatory requirements
- Conduct audits and investigate customer complaints to develop process and product improvement in collaboration with impacted groups
- Establish and maintain relationships with key stakeholders including production, engineering and R&D to ensure business goals are met; ensure interaction during development phases to ensure consideration is given to quality control testing needs prior to the introduction of new products and processes
- Analyze and create reports for management review utilizing statistical models to reflect current state of business operations
- Live our culture and exemplify our Growth Enabling Behaviors to be highly enabled to deliver, highly empowered to succeed and highly accountable to lead.
Position Requirements
- Bachelors Degree in Quality, Engineering or Sciences
- Knowledge & Experience with FDA regulatory and compliance within Medical Devices
- Minimum 5 years Quality or Regulatory Management Experience
- Demonstrated ability to lead indirect teams to achieve business outcomes
Additional Details
Travel 20-30%
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Evoqua Water Technologies prohibits discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, national origin, sexual orientation or any other category protected by applicable federal, state or local law. Evoqua Water Technologies takes affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, national origin, protected veteran status or disability.
EEO is The Law
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation/Gender Identity
Evoqua does not accept unsolicited resumes/candidates from search firms.
Nearest Major Market: Minneapolis