Safecor Health, LLC
  • 25-Jul-2017 to 30-Nov-2017 (EST)
  • Operations - Management
  • Woburn, MA, USA
  • Full Time

Medical, Dental, Vision, Short Term Disability, Life Insurance, PTO, EST, Holiday Pay, 401k


JOB SUMMARY

Under the general direction of the Woburn Operations Manager, the Line Supervisor position is responsible for Supervising all operations of the Woburn, MA Safecor Health Medical production lines including all production and warehouse operations. This role will include a significant amount of initial project management for the validation of a new production lines. In addition, the Line Supervisor is the key supervisor that ensures that the medical kit is packaged in a timely manner, consistent with customer expectations and ensuring the quality and integrity of all pharmaceutical packages that are produced in our state-of-the-art packaging facility.

RESPONSIBILITIES 

Ensures that overall project goals and budget requirements are met in a timely manner.

Performs installation and validation activities to implement a new medical device kitting line.

Supports the project and works with Management to lead the project team through the implementation process.

Provides input to the program prioritization process and participate in other key strategic business portfolio processes to insure that the development programs being funded meet the business' strategic objectives.

Negotiates and resolves conflicts and drive consensus among team/functional members to accomplish project and business goals.

Leads team to identify, and manage, implementation of improvements to production equipment and techniques.

Confers with management team, Operations, and Sales/marketing to determine feasibility, cost effectiveness for new products or potential changes to existing products or packaging.

Oversees personnel who perform packaging activities.

Oversees technicians who perform equipment scheduled maintenance to ensure compliance in task completion and documentation.

Implement operational metrics for shop floor performance improvement programs and lead operations organization in use of key operations metrics.

Leads operations scrap reduction and rate improvement efforts.

Works in collaboration with Quality Assurance, Sales and Customer Service to improve product consistency and quality goals and insure that there is a closed-loop for measurements and process improvement.

Recruits, hires and trains new employees for production, customer service and other areas as needed.

Develops Standard Operating Procedures

Performs Investigations

Participates in inspections conducted by regulatory agencies and customers.

Interacts with contracted customer(s) for implementation of new device packaging.

Plans and establishes production schedules to meet customer demands.

EDUCATION AND EXPERIENCE

Bachelor degree in science or engineering from an accredited college or university preferred

3 to 5 years' experience project manager/product development experience within the medical device, bio or pharma manufacturing industry

Previous change management experience coupled with project management experience in a manufacturing environment

Progressively increasing responsibility in manufacturing or engineering roles

3 to 5 years' experience managing production in an FDA regulated environment, preferred experience in medical device

Ability to understand and implement required guidelines of the 21CFR Part 820 and 21CFR 210 and 211, FDA regulations for drug and medical device manufacturing

Experience working in a Clean Room environment and with sterilized products preferred, but not required

Understanding how to develop and implement standard operating procedures

Process improvement utilizing Six Sigma concepts or other continuous improvement process

KNOWLEDGE, SKILLS AND ABILITIES

Customer Focused

Ability to lead and manage people, processes and outcomes

Strong oral and written communications skills; strong interpersonal skills; demonstrated time management and decision making skills required.

Experience building complex schedules, utilizing sub-schedule integration structure, and performing critical path analyses

Strong attention to detail and a passion for quality

Organization, planning and prioritizing skills

Working knowledge of Microsoft Office

PHYSICAL REQUIREMENTS

Stooping: Bending body downward and forward by bending spine at the waist. Kneeling: Bending legs at knee to come to a rest on knee or knees.

Crouching: Bending the body downward and forward by bending leg and spine.

Reaching: Extending hand(s) and arm(s) in any direction.

Standing: Remaining upright on the feet, particularly for sustained periods of time.

Walking: Moving about on foot to accomplish tasks or moving from one work site to another.

Pushing: Using upper extremities to press against something with steady force in order to thrust forward, downward or outward.

Pulling: Using upper extremities to exert force in order to draw, drag, haul or tug objects in a sustained motion.

Lifting: Raising objects from a lower to a higher position or moving objects horizontally from position to-position.

Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.

Grasping: Applying pressure to an object with the fingers and palm.

Feeling: Perceiving attributes of objects, such as size, shape, temperature or texture by touching with skin, particularly that of fingertips.

Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.

Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction, and having the ability to receive detailed information through oral communication, and making fine discriminations in sound.

Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.

Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.

The worker is subject to inside environmental conditions: Protection from weather conditions but not necessarily from temperature changes.

The worker is subject to hazards: Includes a variety of physical conditions, such as proximity to moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, exposure to high heat or exposure to chemicals.

 

 

 

Safecor Health, LLC
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