Quality Assurance Engineer I

Job Description:

At Confluent, we are committed to our values of teamwork, innovation, accountability, integrity, leadership, and customer focus, and we invest in a team who represents these values. Every member of our team plays a critical role in delivering life-saving medical devices through innovative materials science, engineering, and manufacturing. We are the medical device industry's most trusted partner, and we accomplish this with an organization focused on safety, efficiency, and customer satisfaction.

We are looking for a Quality Assurance Engineer I to join our team in Costa Rica. If you enjoy working in a fast-paced environment and making an impact on our life-saving work, this may be a good fit for you!  As a uniquely qualified candidate, you will:

SUMMARY: Provides direct support to the manufacturing lines. Ensures that the products are being built according to the manufacturing procedures. Ensures that products built meet all the Customer specification requirements. With the guidance of Supervisor/Coach, the Quality Assurance Engineer I is capable of preparing, analyzing and reviewing/approving Engineering and Quality Records related to manufacturing process changes, documentation updates, root cause investigations, validation protocols, etc. Monitors department metrics and presents information when required to other members of the organization.

ESSENTIAL DUTIES AND RESPONSABILITIES:

Soft Skills

Efficiency:

• Oriented to Action:  Willing or likely to take practical ​action to ​deal with a problem or ​situation.
• Prioritization: Being able to work under tight deadlines, set the most urgent tasks at the top of the to-do list. Then, establish a clear deadline for him/herself in advance of the company due dates.
• Problem Solving: Being able to use logic, as well as imagination, to make sense of a situation and come up with an intelligent solution.
• Self-sufficiency: Able to take care of him/herself or to deal with problems, without help from other people

Communication:

• Customer Oriented: Able to communicate with Customers following CMT Values
• Trust and Integrity: being honest, being respectful, adhering to our values, and consistently making positive decisions - even when no one else is looking
• Relationship building, being able to connect with others and form positive relationships contributing to a team and building an understanding between yourself and others Emotional Intelligence:
• Comfortable to deal with direction: possesses a combination of personality traits and behaviors that makes the person easy to work with.
• Composure: exudes a sense of calmness and self-control, even in challenging situations.
• Auto-knowledge: ability to understand their own thoughts, feelings, and motivations. Able to reflect on their strengths and weaknesses, and how their actions might impact others. Open to feedback and willing to learn and grow from his/her experiences.
• Listening Capacity: actively engage in the communication process. Minimize distractions, making eye contact and turning their body towards the speaker. Ask clarifying questions to ensure they understand the speaker's message. Able to pay attention to nonverbal cues like tone of voice, body language, and facial expressions to understand the speaker's emotions.

Entrepreneur Spirit:

• Learning for flight: able to learn new skills, facing challenges, or overcoming obstacles, all with the aim of achieving her/his full potential.
• Organizational agility: quick and effective adapter who thrives in the face of change.

Organizing Priorities/ Overall effectiveness Organization:

• With the help of supervisor/coach, being able to identify the priority of assignments and decide which specific tasks to complete first.
• With minor guidance, obtain the basic knowledge on how to organize the sequence of tasks execution for projects completion.

Communication Skills:

• Written Communication: with the help of the supervisor/coach, able to document Quality Records (NCRs, CAPAs, Complaints, Change packages, Customer Notifications, etc)
• Oral Communication: with the help of the supervisor/coach, able to communicate the applicable messages to other team members from the organization
• Telling a visual Story (Presentations): with the help of the supervisor/coach, able to present information for meetings, NCR summaries, Complaints/CAPA status and Company metrics.
• Metrics Control: Once explained, must be able to monitor and present the specific department applicable metrics assigned (NCRs, COMPs, etc.)

Technical Skills:

• Quality Systems: With the support from Supervisor/Coach, the QE1 must be able to process NCRs, Out of Tolerance Analysis, Quality Plans, Customer Complaints, FAIs, basic FMEA updates. The QE 1 requires training in these activities prior to execution and will also require additional support during the different stages of each Figure within the Quality System as part of the knowledge increase in the role.
• Validations: With the support from Supervisor/Coach, the QE1 must be able to understand the principles of validations in all applicable areas: Equipment, Test Methods, Software and Process. The QE 1 should be able to prepare, review and approve Validation protocols/Reports/Strategies for all specific applicable projects ongoing in the production lines related to each of the impacted validation areas. The QE 1 requires training in these activities prior to execution and will also require additional support during the preparation/review of the different records part of the Validations scope.
• Change Management: With the support from Supervisor/Coach, the QE I must be able to prepare, review and approve Change packages related to Customer Requests, Internal initiatives, Supplier changes, etc that has a direct impact to the manufacturing lines that he/she provides support. The QE 1 requires training in these activities prior to execution and will also require additional support during the preparation/review of the different records.
• Must be able to navigate the Documentation Management system with no issues and identify all the applicable modules that are needed for this role and assigned tasks.
• Equipment/Tooling/Process Knowledge/Data Analysis:
• Must have complete knowledge of the manufacturing process of the line (s) that is providing direct support. Must be able to explain the manufacturing process to any Customer and/or visit when needed.
• Must have complete knowledge of the Lot Release Testing activities for the products being supported. Must be able to also explain the testing sequence and details to any Customer and/or visit when needed.
• With the help of Supervisor/Coach, must be able to prepare and review Statistical Analysis of data that supports change packages, validations, improvement projects, etc. The QE 1 requires training in the Statistics concepts (Process Capability, Tolerance Intervals, Distribution identifications, Comparisons, etc) and will also require additional support during the preparation/review of the different data analysis.
• Basic knowledge in Incoming Inspection activities, Packaging/Labeling, Sterilization, Shipping, Inventory management.

Lean Manufacturing:

• Must have complete control of 6S around his work station and the manufacturing lines.
• Must manage a Standard Work tool for arranging the workload.
• Must be able to obtain preliminary analysis of Business cases for improvement ideas
• Full understanding of Yield calculation and analysis

Finance:

• Understanding of general concepts as: Material Usage Variance, Manufacturing Cost, Labor, Scrap, Return of Investment (ROI), etc
• Other Systems (ERP, PLM, Power BI, Minitab, etc):
• Must be able to navigate through the ERP system, complete Purchase Requests and obtain all different production reports that could support root cause investigations, validation records, data analysis, etc.
• Must be able to navigate through the Documentation system and must be capable of working with all applicable modules for consulting documents, reviewing and approving changes, complete trainings, moving phases, etc.
• Basic knowledge in the Minitab software for all the applicable tools for Statistical Analysis of data.

SUPERVISORY RESPONSIBILITIES:

Have supervisory responsibilities: No

Leadership: No

Supervises: N/A

Supervision:

General Direction: the QE1 needs to receive guidance with respect to overall objectives and work; operate within division or department policy guidelines using independent judgment in achieving assigned objectives.

EDUCATION and/or EXPERIENCE:

Bachelor´s degree in a related engineering discipline; 0-2 year of related experience. Medium oral and written English level. Experience in the medical device industry would be an asset. Certification and/or license in specific discipline would be an asset. Certified Quality Engineer would be an asset. Training as Internal Auditor in ISO 9001, 13485 or Biomedical field would be an asset.

OTHER SKILLS and ABILITIES:  

Knowledge of precedents, principles and practices of related specialties would be an asset. Experience and knowledge in Process Validation in the Medical Device Industry would be an important asset.

Knowledge of statistics and Minitab would be an asset.

Customer service, quality focus, problem solving, market knowledge, documentation skills, confidentiality, analyzing information, multi-tasking, and project management skills.

Ability to read, analyze, and interpret technical documents. Ability to write speeches and articles for publication that conforms to prescribed style and format. Ability to effectively present information to public groups among the natural working team.

Ability to define problems, collects data, establishes facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Proficient personal computer skills including electronic mail, record keeping, routine database activity, word processing, spreadsheet, graphics, etc.

MANUAL DEXTERITY: No special requirements.

VISION REQUIREMENTS: No special vision requirements

WORK SCHEDULE/HOURS: Monday – Friday.

TRAVEL: Minimal

ENVIRONMENTAL WORKING CONDITIONS

Well-lighted, heated and/or air-conditioned indoor office setting with adequate ventilation.

PHYSICAL DEMANDS

Other physical working conditions:     

Lifting or carrying items.

Moderate noise (examples: business office with computers and printers, light traffic)

PHYSICAL ACTIVITY LEVEL: Moderate physical activity moving around the manufacturing process and offices areas, as well as performing somewhat strenuous daily activities of a primarily administrative nature.

COMMENTS:  This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.