Team Lead, Instrument Manufacturing
Description Business Title - Team Leader, Instrument Manufacturing Department - Instrument Manufacturing Cost Center - 2102003 Title of Direct Supervisor - Associate Director , Instrument Manufacturing Position Summary Responsible for front-line leadership of a team engaged in the operations of assembling, testing, and labeling medical equipment within the Instrument Manufacturing Department.
Includes all aspects of these activities as well as daily main t ena n ce work, quality, and cleanliness of the work area.
Effectively leads quality initi atives critical to the department's ability to improve manufacturing processes, increase product quality, improve productivity /efficiency, and reduce cost/scrap.
Primary Duties Assist in the assignment of daily activities such as labor needs, breaks, and lunches.
Monitor daily output and assist with assembly, testing , shutdown, or packing of units in order to meet demand.
Provide support and training to the team.
Organize and lead any rework as directed.
Ensure overall team training is current and maintained for processes and procedures relevant to all manufacturing activities and coordinate cross-training among roles to create staffing flexibility and increased depth.
Assist in maintaining an efficient and effective workforce.
Maintain GMP compliance and meet FDA and ISO requirements.
Contribute to team goal development, status tracking , and communication by providing feedback to the direct manager/Associate manager for PMP evaluation.
Lead and promote continuous improvement through team and individual initiatives.
Identify areas of defici ency and implement practices to improve employee safety.
Provide assistance with the creation, review, and revision of SOPs.
Assist with Manufacturing investigations, SAPA actions, and other process equipment related quality concerns.
Supplemental Data Information that will enhance the understanding of the nature of the job (e.
g.
, number of people directly supervised , total staff supervised, sales volume impacted, operating, budget, extent of travel required, etc.
) N/A Training and Education Minimum 6 years' experience in FDA regulated manufacturing environment and GMP is desired.
Education High School Diploma or GED Will work experience be accepted in lieu of a degree? No Experience Minimum 6 year s' experience in FDA regulated manufacturing environment and GMP is desired.
Prior experience in a leadership role is desired.
Knowledge, Skills, and Abilities Oversee Manufacturing daily activities and /or performing the record review to ensure adherence to the appropriate departmental procedures.
Ensure all processes and procedures that are performed are documented in a timely manner in accordance with company and regulatory regulations.
Ensure that Manufacturing documentation is prepared and completed according to compa ny policies and procedures to support manufacturing, maintenance of device history records, log/logbooks, and training requirements consistent with cGMP, ISO, and all applic able regulatory policies/regulations.
Working Conditions and Physical Requirements Ability to remain in stationary positi on, often standing, for prolonged periods.
Ability to adjust or move objects up to 50 pounds in all directions.
Ability to push/pull objects up to 150 lbs.
Operating with a limited space inside an instrument.
Supervisory Responsibilities Indirect supervision of approximately 15 people Management Scope /decision making authority Decisions with long-term impact With supervisory review/approval required.
Deci sions with short-term impact With little-to-no supervisory impact Recommended Skills Assembly And Installation Business Process Improvement Certified Project Management Professional Decision Making Leadership Maintenance Estimated Salary: $20 to $28 per hour based on qualifications.
Includes all aspects of these activities as well as daily main t ena n ce work, quality, and cleanliness of the work area.
Effectively leads quality initi atives critical to the department's ability to improve manufacturing processes, increase product quality, improve productivity /efficiency, and reduce cost/scrap.
Primary Duties Assist in the assignment of daily activities such as labor needs, breaks, and lunches.
Monitor daily output and assist with assembly, testing , shutdown, or packing of units in order to meet demand.
Provide support and training to the team.
Organize and lead any rework as directed.
Ensure overall team training is current and maintained for processes and procedures relevant to all manufacturing activities and coordinate cross-training among roles to create staffing flexibility and increased depth.
Assist in maintaining an efficient and effective workforce.
Maintain GMP compliance and meet FDA and ISO requirements.
Contribute to team goal development, status tracking , and communication by providing feedback to the direct manager/Associate manager for PMP evaluation.
Lead and promote continuous improvement through team and individual initiatives.
Identify areas of defici ency and implement practices to improve employee safety.
Provide assistance with the creation, review, and revision of SOPs.
Assist with Manufacturing investigations, SAPA actions, and other process equipment related quality concerns.
Supplemental Data Information that will enhance the understanding of the nature of the job (e.
g.
, number of people directly supervised , total staff supervised, sales volume impacted, operating, budget, extent of travel required, etc.
) N/A Training and Education Minimum 6 years' experience in FDA regulated manufacturing environment and GMP is desired.
Education High School Diploma or GED Will work experience be accepted in lieu of a degree? No Experience Minimum 6 year s' experience in FDA regulated manufacturing environment and GMP is desired.
Prior experience in a leadership role is desired.
Knowledge, Skills, and Abilities Oversee Manufacturing daily activities and /or performing the record review to ensure adherence to the appropriate departmental procedures.
Ensure all processes and procedures that are performed are documented in a timely manner in accordance with company and regulatory regulations.
Ensure that Manufacturing documentation is prepared and completed according to compa ny policies and procedures to support manufacturing, maintenance of device history records, log/logbooks, and training requirements consistent with cGMP, ISO, and all applic able regulatory policies/regulations.
Working Conditions and Physical Requirements Ability to remain in stationary positi on, often standing, for prolonged periods.
Ability to adjust or move objects up to 50 pounds in all directions.
Ability to push/pull objects up to 150 lbs.
Operating with a limited space inside an instrument.
Supervisory Responsibilities Indirect supervision of approximately 15 people Management Scope /decision making authority Decisions with long-term impact With supervisory review/approval required.
Deci sions with short-term impact With little-to-no supervisory impact Recommended Skills Assembly And Installation Business Process Improvement Certified Project Management Professional Decision Making Leadership Maintenance Estimated Salary: $20 to $28 per hour based on qualifications.
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