Maintenance Leader

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POSITION SUMMARY:

The Maintenance Lead position is assigned with providing support associated with the manufacturing processes and facilities at Argentum Medical's (Bravida Medical's) campus of facilities, in Geneva, IL.

The Maintenance Lead primarily participates in the execution or supervision (when contracted) of maintenance activities associated with production and facility equipment, instrumentation, and structures (where applicable). This may include existing or new process/equipment integrations as well as supporting ongoing production activities through appropriate equipment performance. This position also involves the performance of calibration activities for critical process equipment and/or instrumentation as designated by Argentum's QMS.

This position works at the direction of the Director of Engineering and serves as a key member of the Engineering and Operations team with regard to production process and facility support. This position will require working inter-departmentally with the Operations, Engineering, and the Quality and Regulatory Affairs (QRA) teams and indirectly supports the VP of Operations and Plant Manager with regard to process performance. ESSENTIAL FUNCTIONS (ACCOUNTABILITIES/RESPONSIBILITIES):

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Execute/coordinate and document maintenance and calibration activities associated with production processes:

In a safe and professional manner.

Using best practices (recommended materials and techniques).

In accordance with established QMS and/or manufacturer's instructions.

In accordance with applicable codes/ordinances.

Troubleshooting and repair of manufacturing/facility equipment/instrumentation in break-fix scenarios.

Manage maintenance consumables and notify purchasing of expected shortages.

Improve existing and develop new maintenance and calibration instructions and records as necessary.

Actively participate in Argentum's Safety Program to help drive a safe and collaborative work environment.

Assist in the commissioning of equipment including performance of factory acceptance testing (FAT), site acceptance testing (SAT), and/or process validations, including IQ, OQ, and PQ phases.

Provide technical support to the Quality & Regulatory Affairs department when requested (non-conformance, CAPA, audits, training, etc.).

Execute or coordinate with suppliers regarding facility maintenance and improvement activities.

Conduct regular site inspections to ensure optimal performance related to safety and maintenance.

Other duties as assigned.

QUALIFICATIONS:

Experience

Minimum of 5 years of experience in a highly regulated industry (aerospace, medical device, pharma) related to process and equipment integration, maintenance, training, and/or process improvement.

Successful track record working in a collaborative environment.

Knowledge and experience in the application of section 820 of 21 CFR and/or ISO 13485 QMS requirements is preferred but not required.

Education

High school diploma

Technical certificate(s) applicable to the primary job functions herein

Professional certifications (preferred but not required)

Lean Six Sigma

General Skills/Competencies/Specialized Knowledge

Communication - Communicates effectively at all levels of the organization. Expresses ideas clearly and simply both verbally and in writing. Promotes timely, ongoing flow of information to others. Communicates and listens effectively in order to develop and maintain key business relationships.

Interpersonal Skills - Ability to work cohesively with co-workers and suppliers. Ability to professionally interact and build constructive and effective relationships with all levels and functions. Ability to effectively interface with others (suppliers and internal leadership) on behalf of the organization.

Presentation Skills - Ability to present one on one, or in a small group (3-5 people) setting.

Initiative - Ability to work well independently and exercise appropriate judgment under general direction. Ability to prioritize workload, goals, and tasks consistent with the department objectives. Ability to take direction from multiple sources and manage conflicting priorities with the Director of Engineering in an effective and efficient manner.

Problem Solving - Uses logic to solve problems. Probes various sources for answers.

Decision Making - Makes timely, sound decisions based on analysis, wisdom, experience, and judgment independently or under the guidance of the Director of Engineering. Relies on experience and good judgment to ensure that expectations are met.

Adaptability - Embraces and adapts to change and demonstrates a willingness to learn. Reactionary and adaptable to abrupt changes, arising issues, time pressures, and other circumstances. Ability to respond quickly to change, and to prioritize actions to meet reasonable deadlines.

Trust and Integrity - Interacts with others in a way that gives them confidence in one's intentions and those of the organization. Accepts responsibility for one's own decisions and actions. Demonstrates honesty. Keeps commitments. Behaves in a consistent manner and is open, honest, and trustworthy.

Collaboration and Teamwork - Works collaboratively and cooperatively with teams cross-functionally. Ability to work well with other people to solve problems and to find the best solution. Energetic and willingness to work closely with all team members to achieve success.

Computer Skills - Moderately proficient with computer system based tools including Microsoft Office applications, presentation, e-mail, web browsers, and willingness to learn other technical software suites as requested (QT9).

TRAVEL REQUIREMENTS/WORK ENVIRONMENT AND PHYSICAL DEMANDS:

Travel

Must be willing to travel up to 10% of the time although this is not anticipated.

Work Environment and Physical Demands

Medical device production and storage areas - 90%

Cleanroom cutting and packaging

Silver-plating production rooms

Storage warehouses

Facility maintenance areas

Typical office environment - 10%

Ability to lift up to 40 pounds from floor - reasonable accommodations will be made as necessary