1+ months
2018-06-272018-08-24

Quality Manager - Process Validations

Abbott
Westford, MA 01886

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.

Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.

Monitors daily work operations and provides direction and guidance to, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.

Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.

Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.

Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.

Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc).

Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.

Translates department goals into individual objectives and KRAs.

Identifies, develops and implements processes to improve department performance.

Monitors departmental activities and records to ensure compliance independent action through critical decision making.

Provides manufacturing support by defining work assignments directed to address manufacturing process defects and implement process improvements utilizing Quality System tools.

May also direct work assignments for quality control auditors.

Directs Quality personnel to support new product development by defining projects focused on new products/process development based on coordination with management, project leaders, & design engineers.

Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.

Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.

(Influence/Leadership) Promotes the attainment of group goals by selecting, motivating, and training capable staff. Provides leadership to assigned units by communicating and providing guidance towards achieving group objectives.;

(Planning/Organization) Schedules human and material resources within a group or section in conjunction with near-term plans to ensure their availability; carries out operations within an established budget.;

(Decision Making/Impact) Assignments are expressed in the form of tasks and objectives; generally makes day-to-day decisions within established guidelines regarding work processes or schedules in order to achieve the program objectives established by senior management; consequences of erroneous decisions would normally result in serious delays to assigned projects or operations with substantial expenditure of time, human resources, and funds, without jeopardizing future business activity.

Education/Experience

Bachelor's degree (Engineering) and 9+ years of related work experience or an equivalent combination of education and work experience. Advanced degree preferred.  

* Software or Hardware development certifications a plus

* CQE a plus

* Six Sigma Black Belt a plus

* Process development engineering in manufacturing a plus

(Technical/Business Knowledge (Job Skills)) Monitors progress of exempt individuals, teams, supervisors or nonexempt technical individuals toward departmental goals; monitors costs of projects and of human and material resources within a department or unit; monitors external environment in area of technical or professional responsibility. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.

(Cognitive Skills) Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned area or related departments; facilitates others involvement in the continuous improvement program; investigates and solves problems that impact work processes and personnel within the assigned unit.

TRAVEL UP TO 25% - Domestic/International


Job Family: Operations Quality
Division: AVD Vascular
Travel: Yes, 25 % of the Time
Medical Surveillance: Yes
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Quality Manager - Process Validations

Abbott
Westford, MA 01886

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