Job Title

Manufacturing Supervisor, Medical Device

Requisition

JR000014188 Manufacturing Supervisor, Medical Device (Open)

Location

CC-Madison - USA503

Additional Locations

Madison, WI

Job Description

The Manufacturing Supervisor, Medical Device or is responsible for on the floor oversight of day-to-day manufacturing operations to ensure the performance, productivity, and efficiency of the production team. Responsible for supporting the overall GMP Manufacturing process through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production area. The Manufacturing Supervisor, Medical Device will be responsible for leadership of operations hourly team members. In addition, this role will work closely with the Supply Chain team, Sustaining Engineering, Manufacturing Engineering, and Quality to ensure work conforms to company quality systems, ISO 13485, and customer and company requirements are met.

Essential Functions

• Review production orders, production schedules, visible parts supplies, and other reports to provide production completion estimates against ongoing business goals.

• Provide operational leadership for day-to-day cGMP device manufacturing production and activities.

• Perform and document all assembly, test and repair work per established work rules, policies, and procedures.

• Work with Manufacturing, Supply Chain, Quality Assurance, and Management teams to effectively troubleshoot to assure customer requirements can be met.

• Collaborate with Quality Assurance to ensure Production processes and methods are maintained on the floor and within compliance.

• Assist in development and revisions of Standard Operating Procedures (SOP), Work Instructions (WI) device history records, or other quality documentation, as necessary, to support production processes.

• Provide continuous improvement suggestions for methods, technology, utilization of time and resources to help the team more effectively achieve business goals and objectives.

• Perform initial review and/or final sign-off of executed cGMP documentation such as batch production records, deviations, or forms, as needed.

• Support team with ongoing coaching, training, and performance feedback.

• Serves as a key part of new hire selection and onboarding process.

• Serve as point of escalation contact for equipment malfunctions and off-shift issues, as necessary.

• Serve as a Subject Matter Expert on the material review board, supplier selection team, and supplier development team.

• Ability to work scheduled/expanded shifts, holidays and/or off-shift duties, as necessary.

• Other duties as assigned.

Minimum Requirements

• 5+ years of experience in Medical Device cGMP manufacturing or equivalent combination of manufacturing experience.

• Ability to work independently and motivate staff to meet required deadlines.

• Proficiency in time management.

• Strong Leadership, coaching, and effective communication abilities.

• Proven track record in enhancing employee engagement and fostering career growth.

• Demonstrated capacity to handle numerous intricate projects concurrently.

• Ability to work scheduled/expanded shifts, holidays and/or off-shift duties, as necessary.

Preferences:

• Bachelor’s degree in related field.

• Prior people management or supervisor experience.

• Advanced SAP knowledge.

• General knowledge of Lean Management and Process Improvement techniques.

Organizational Relationship/Scope:

A Manufacturing Supervisor, Medical Device is a team leadership role reporting directly to the Manufacturing Manager, Medical Device. The primary responsibility is the oversite and management of the local device manufacturing team and will work closely with the Supply Chain, Sustaining Engineering, Manufacturing Engineering, and Quality Assurance teams. In addition, the device manufacturing team interfaces daily with Quality departments including Quality Assurance and Quality Control.

Working Conditions:

The role of Manufacturing Supervisor, Medical Device is a leadership role within the operations department; however, it will require performing hands-on value-add operations for device manufacturing. Work will be split between managing and completing device manufacturing operations and attending meetings, preparing presentations, and interfacing with site management.

#LI-LM1

Mallinckrodt is a global specialty p harmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.

To learn more about Mallinckrodt, visit www.mallinckrodt.com.

Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.

Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.