Quality Engineer I

Job Description
Additional position details from the manager below:

• Can you please confirm your top 3 skills sets required?

• Detail oriented, organized, collaboration & communication

• Can you please confirm the 3 main responsibilities/day to day activities required for this role?

• Reviewing proposed manufacturing, supplier, and design changes to commercially released product

• Complaint trending to determine if there are any signals that need to be escalated

• Risk management document ownership

• What products (if any) will this role support?

• Cardiac Surgery perfusion products

• What is your target years of experience?

• 0 – 2 years

TECHNICAL SKILLS

Must Have

Bachelor's Degree in Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality.

Nice To Have

• Bachelors or Masters Degree in Mechanical Engineering, or other related engineering degree strongly preferred.
• Experience in medical device design and application of test standards.
• Experience in application statistical methods to design reliability and process capability.
• Certified Quality Engineer, Reliability Engineer, or equivalent desired.
• Strong oral and written communication skills.
• Cross-functionally and an effective team player.
• Excellent presentation skills.
• Must be able to handle multiple tasks/projects and manage priorities accordingly.
• Working knowledge of appropriate industry standards.
• Must be able to work in a team environment and exert influence without alienating others.
• Knowledge/basic understanding of specification development, industry standards, geometric dimensioning and tolerancing (GD&T), etc.

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Responsibilities may include the following and other duties may be assigned.

Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.

Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

Responsible for post-market quality supporting including complaint trending, released product manufacturing and design changes, CAPA support, complaint investigations, real-time age testing, and statistical analysis.

Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS

Autonomy: Entry-level individual contributor on a project or work team.

Works with close supervision.

Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.

Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.

Makes minor changes in systems and processes to solve problems.

Communication and Influence: Communicates primarily with internal contacts within immediate group.

Contacts others to gather, confirm and convey information.

Leadership and Talent Management: N / A – job at this level is focused on self-development.

Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education.

Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R.

• 214.2(h)( 4)(iii)(A), 0 years of experience required.

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.