Quality Engineer II

4 weeks ago

Minneapolis, United States ATR International Full time

Job Title: Reliability Engineer II

Type: Contract - 6 Months

Pay: Can Be Flexible - $35.00-$50.00/hr

Onsite to start for training. Then 3-4 days per week onsite thereafter.

Location: 7000 Central Ave NE, Minneapolis, MN


As a Reliability Engineer II, you will maintain systems to support Field Corrective Action activities and Product Non-Conformances.

You will work with partners at the Enterprise level to ensure that our documentation is filed according to the plans and in a timely manner.

You will obtain information form our different databases to scope issues in support of Product Holds and Field Actions.

You will also play a key role in activities to ensure conformance to FDA regulations and Client procedures.

You will collaborate with all the Post Market Quality group in providing data to support non conformances product disposition.

Responsibilities may include other duties as assigned.


What products (if any) will this role support? Supporting the Neuromodulation and Pelvic Health Product portfolios at the Company


The ideal candidate will possess the following qualifications:


TECHNICAL SKILLS

Must Have

1. Computer literacy in MS Word, Excel PowerPoint

Ability to navigate different software systems and manipulate data

Dynamic team player with good communication skills

Extremely detailed oriented

Organizational and planning skills


Nice To Have

Document Control Specialist

Experience in medical devices or other highly regulated industry

Good documentation practices experience



Can you please confirm your top 3 skills sets required? Great Communicator ( Email, verbal, cross-functional, written/phone – possibly calling sites to follow-up, etc.), Organized, Fast Learner/Self-Starter, QMS knowledge is a plus ( understanding and experience with Quality in their background). Specifically post-market quality.

What is your target years of experience? 1-5 years of experience


SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.

DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 1 years of relevant experience, or advanced degree with 0 years of experience.

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