Manufacturing Supervisor, Instruments - 2

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.

Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."

Why Join Diasorin?

• Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.

• Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.

Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.

Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.

Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

Job Scope

This position will assume principal ownership of defined Manufacturing sections and/or product lines with responsibility for supervising associated manufacturing staff of moderate to high span of control and/or skill level. This position will be responsible in delivering manufacturing requirements according to production schedules for those products including manufacturing requirements for support of new product integration, process development, equipment validations, and process validations, leads and engages production team employees, plans, coordinates, and supervises the daily activities of their assigned Manufacturing section and/or product lines to ensure efficient production and set the daily schedule, priorities, and task delegation and managing resources to execute the production schedule. The Manufacturing environment is a high complexity, small/large run production environment and this position will be responsible for standard and custom Luminex instrument product lines manufactured in an environment that is ISO certified and includes products that are FDA regulated.

Key Duties and Responsibilities

• Coordinate (developing and implementation) the daily work schedule, priorities, and task delegation within a work section
• Supervise associated manufacturing personnel
• Establish, execute and maintain appropriate role-specific training plans; ensure that each team member is properly trained on systems, processes and equipment.
• Deliver manufacturing requirements and attainment of production schedule for responsible Manufacturing section and/or product lines, qualification/processing of incoming materials, production intermediates, and stability samples
• Deliver timely completion of manufacturing sections of process documentation and related business system transactions
• Oversee section cycle counts; deliver timely completion of cycle counts and physical inventory
• May oversee specific calibration and maintenance of manufacturing equipment and infrastructure.
• Document non-conformances and participate in Material Review Board.
• Participates in the integration of new products and processes into the Manufacturing organization; participates in validation and integration of new products and processes; participates in design transfer teams as required
• Identify process improvements to improve quality and efficiency. Participate in sustaining projects for improvement of manufacturing processes, cleaning processes, product specifications, process/test equipment/fixtures, analysis tools, and business systems
• Participate in/execute equipment and process validations
• Participate in or lead investigations and resolution of findings impacting the Instrument Manufacturing Organization identified through audits, non-conformances, corrective/preventive actions, or customer complaints escalation
• Develop and/or updates of work instructions for new and/or improved processes
• Maintain cleanliness and integrity of manufacturing and storage areas
• Lead and/or participate in departmental and interdepartmental training; maintain current training to standard operating procedures per matrix, work instructions, and applicable changes affecting the Manufacturing departmental training compliance
• Interface with other departments as required; represents the department on internal committees and project teams as assigned.
• Maintain personal compliance and facilitate departmental compliance with the Quality Management System.
• Adhere to safety, disposal, and/or gowning requirements; facilitate departmental compliance
• Perform change control review as required to support change requirements including Engineering Change Orders, Document Change Control, and Deviations. Take ownership of section task-specific and change control training
• Drive document change control and basic engineering change control activities specific to Manufacturing section and/or product lines.
• May manage Manufacturing section and/or product line specific labor routings and lead times for optimal accuracy; facilitate definition of labor routings and lead times for new product introductions.

Education, Experience, and Qualifications 

• Associate's Degree Associates of Science degree in the field of Engineering/Engineering Technology or related field degree with equivalent amount of experience required or
• Bachelor's Degree Bachelor of Science degree in the field of Engineering/Engineering Technology or related field preferred
• 5+ Years Relevant experience in a manufacturing environment in an FDA regulated industry and/or ISO certified organization with a Bachelor’s Degree preferred
• 8+ Years Relevant experience in a manufacturing environment in an FDA regulated industry and/or ISO certified organization with an Associate Degree required
• 2+ Years Relevant Manufacturing Operations leadership experience required
• Mathematics aptitude (High proficiency)
• Knowledge of Electro-Mechanical Assembly (High proficiency)
• Statistical aptitude (Low proficiency)
• Knowledge of clean manufacturing environments (Low proficiency)
• ISO 13485 and FDA Quality System knowledge (Medium proficiency)
• Proficiency in use of process-based Manufacturing Resource Planning systems such as Oracle or SAP (Medium proficiency)

What we offer

Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.

Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation.

The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.

Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.

Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.

This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.