Supervisor, Manufacturing Operations

Integra-Lifesciences; Mansfield (MA); On-site; USD 81,650 - 112,700; Full time

Job summary

Integra LifeSciences is seeking a Supervisor, Manufacturing Operations in Mansfield, MA to lead daily production activities across Machining, Packaging, and Boxing for multiple product lines. You will ensure safety, quality, and on-time delivery while managing costs and engaging the team.

Responsibilities include directing staff, maintaining records, and coordinating with QA and Materials Management to optimize material flow and compliance with GMP, FDA, ISO standards.

Qualifications

• Bachelor’s degree or higher in Science, Engineering, or related fields is desired.
• 3+ years of leadership experience in a GMP regulated industry.
• Knowledge of NCs and CAPAs.
• Strong written and verbal communication skills.
• Must be able to gown into ISO 7 and ISO 5 Clean Room gowning.
• Batch manufacturing experience.
• Familiarity with FDA regulations, ISO 9001, ISO 13485 and other standards.
• Strong computer skills, including Microsoft Office.
• Automation experience is preferred.
• Knowledge of Oracle R12/Agile is preferred.
• Lean/Six Sigma is a plus.

Responsibilities

• Direct daily production activities and staff in Machining, Packaging, Boxing.
• Meet daily production goals and report progress at shift/tier meetings.
• Operate, troubleshoot, and adjust process equipment; escalate unresolved issues.
• Maintain logs, records, and inventory for WIP activities.
• Place purchase requisitions for general processing supplies.
• Lead operations in cleanroom environment and ensure environmental controls.
• Support NCR/CAPA/Audit investigations and regulatory compliance.
• Plan and lead process improvements and Lean initiatives to boost performance.
• Collaborate with QA and Materials Management to ensure smooth flow of materials.
• Coach and mentor staff; manage admin tasks (timecards, trainings, etc.).
• Maintain safe, compliant, and organized work areas consistent with GMP.

Skills

Leadership

GMP knowledge

Regulatory awareness

Lean/Six Sigma

Communication skills

ISO 7/ISO 5 gowning

Microsoft Office

Automation experience

NCs & CAPAs

Oracle R12/Agile

Education

Bachelor's degree in Science/Engineering

Tools

Oracle R12/Agile

Job description

Changing lives. Building Careers.Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.This Supervisor, Manufacturing Operations will lead and direct all activities in the manufacturing area at Integra's Mansfield, MA manufacturing facility. This site manufactures medical devices primarily used in Neurosurgical applications. The Supervisor, Manufacturing Operations is responsible for supervising production personnel to maximize safety, quality, delivery, cost and engagement metrics in the manufacturing operation. Accountable for achieving production targets while maintaining cost controls.SummaryThis position will lead and direct all activities in the manufacturing area at Integra's Mansfield, MA manufacturing facility. This site manufactures medical devices primarily used in Neurosurgical applications. Responsible for supervising production personnel to maximize safety, quality, delivery, cost and engagement metrics in the manufacturing operation. Accountable for achieving production targets while maintaining cost controls.Job DescriptionResponsible for directing the daily production activities and staff in the Machining, Packaging, Boxing areas in support of multiple product lines.Ensure daily production goals are met and report production line progress at shift and tier meetings.Ability to operate, maintain, troubleshoot process equipment, and make minor adjustments as needed. Escalate issues that cannot be triaged or resolved.Accurately maintain all entries into all required logs, log books and records pertaining to Machining, Packaging, Boxing and other work-in-progress related (WIP)activities. Responsible for maintaining process and component inventories. Place Purchase Requisitions for general processing supplies.Leads operations in cleanroom environment and assurances proper environmental controls and behaviors of team.Support any Non-Conformance/CAPA/Audit related investigations.Responsible for maintaining legible and accurate records and other procedures to comply with regulatory requirements, Good Manufacturing Practices (Quality Systems Regulations) and Standard Operating Procedures.Plan and lead manufacturing process improvements, and other Lean initiatives to optimize performance and drive short-term and long-term business improvements.Support and participate in cross-functional teams.Coach, counsel, train and motivate staff— provide clear direction and oversight of staff in effectively carrying out their daily responsibilities.Perform administrative duties (e.g. review and approve timecards, overtime, absenteeism reports, place purchase requisitions, maintain training records, etc.)Maintain a clean and orderly work area and perform all work in compliance with Good Manufacturing Practices (Quality Systems Regulations), and Standard Operating Procedures, and Health and Safety requirements.Interface with QA department during normal course of work to coordinate inspections of completed product and to interface with the Materials Management Department to ensure efficient flow of materials through operations.Demonstrate safe behavior and support department/plant Safety goals in a continuous improvement process.Perform other related duties as expected.Works with Manufacturing Engineering and Product Development to improve yield and reduce scrap.RequirementsBachelor’s degree or higher in Science, Engineering, or related fields is desired or equivalent combination of education and relevant leadership experience in a regulated environment will be considered.3+ years of relevant leadership experience in a GMP regulated industry.Knowledge of NCs and CAPAs.Must have strong written and verbal communication skills. Must possess strong leadership skills with team-focused attitude and approach.Must be able to gown into ISO 7 and ISO 5 Clean Room gowning.Batch manufacturing experience.Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other National and International regulations and standards.Strong computer skills, including Microsoft Office experience required.Automation experience a preferred.Knowledge of Oracle R12/Agile preferred.Understanding of Lean/six Sigma a plus.Salary Pay Range:$81,650.00 - $112,700.00 USD SalaryOur salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.Additional Description for Pay Transparency:Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciencesIntegra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:EEO Is the Law | EOE including Disability/Protected VeteransIntegra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [e-mail] Agency SubmissionIntegra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.Integra - Employer Branding from Integra LifeSciences on Vimeo