Operations Leader

Company: American Surgical CompanyJob Title: Operations LeaderLocation: Salem, MASummary: This operations leader is responsible for overseeing the production, procurement, logistics, equipment, facilities and infrastructure related to the development and production of medical devices. Duties include, but are not limited to, formulating strategy within the scope of operations, ensuring compliance, and continually improving processes to increase efficiency and reduce waste.Essential Duties and ResponsibilitiesReports applicable metrics, issues, and opportunities during Level 10 meetings.Oversees departmental projects and ensures appropriate controls, approvals, and validation requirements are implemented.Manages development and improvement projects for products and processes and ensures they are completed on time and on budget.Oversees transfer of new products from development to manufacturing.Drafts departmental budget for approval and ensures that expenses are within the approved budget.Establishes KPI's for each function in alignment with department goals.Responsible for drafting and ensuring execution of strategic plan for production equipment.Oversees capital equipment procurement or fabrication.Oversees general facilities maintenance and repair activitiesOversees material procurementControl inventory levels and ensure availability of material.Develops or revises standard operational and working practices and observes workers to ensure compliance with standards.Implements safety, quality, and lean initiatives.Ensures the shipping process is adequate to meet customer demand.Participates in Risk Management Process in accordance with ASC Risk Management ProgramCarries out supervisory managerial responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance, rewarding, and disciplining employees; addressing complaints and resolving problems.Continually looks for ways to improve processes and reduce waste throughout operations.Skills:To perform the job successfully, an individual should demonstrate the following competencies:Experience working in a regulated environment.Familiarity with Lean Six Sigma methodology, Kaizen, and/or 6S.Familiarity with ISO 13485, ISO9001, or any other quality standardsExperience establishing and using Statistical Process ControlsIdentifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.Pursues training and development opportunities, shares expertise with others.Focuses on solving conflict; listens to others without interrupting; remains open to others' ideas and tries new things.Desire and aptitude to coach and mentor team members.Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions.Writes clearly and informatively; able to read and interpret written communication.Delegates work assignments; matches the responsibility to the person; gives authority to work independently; sets expectations and monitors delegated activities; provides recognition for results.Takes responsibility for subordinates' activities; makes self-available to staff; continuously works to improve supervisory skills.Looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.Develops and implements cost saving measures; conserves organizational resources.Treats people with respect; keeps commitments; works ethically and with integrity.Makes timely decisionsUses time efficiently; plans for additional resources; organizes or schedules other people and their tasks.Approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.Experienced in following and creating safety procedures and continually has a safety-first mindsetObserves safety and security procedures; determines appropriate action beyond guidelines, reports potentially unsafe conditions; uses equipment and materials properly.Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays or unexpected events.Is consistently at work and on time; ensures work responsibilities are covered when absent; arrives at meetings and appointments on time.Follows instructions; responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with alternate plan.Volunteers readily; undertakes self-development activities; seeks increased responsibilities; asks for and offers help when needed.Displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.Education and Experience:Bachelor's degree from four-year college or university; or five to ten years related experience in a regulated environment and/or training; or equivalent combination of education and experience.

Created: 2025-02-10