Supervisor, Manufacturing - 2nd Shift

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POST DATE 9/14/2016
END DATE 10/18/2016

GenMark Diagnostics, Inc. Carlsbad, CA

Carlsbad, CA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
High School Diploma or GED



The Opportunity:

Provide leadership and technical support to the manufacturing organization. Assist in development of, drive and achieve departmental short and long-term goals. Drive the manufacturing organization to achieve New Product Development, Continuous Improvement, Quality, Compliance and Operational objectives.

Essential Duties and Responsibilities

* Supervise production personnel and activities to effectively meet forecast, customer demand, R&D and New Product Introduction requirements.

* Develop and execute manufacturing training plans to ensure proper resources and talent are in place to support manufacturing requirements.

* Develop production schedules in alignment with forecast and customer demand.

* Develop, implement, analyze, summarize and report key performance indicator data and metrics for areas of responsibility. Responsible for identification of root cause and implementation of sustainable corrective actions for missed targets.

* Responsible for ensuring compliance to quality systems (FDA, GMP, QSR, ISO), product specifications, process instructions, safety requirements and company policies.

* Responsible for identification, resolution and follow-up on manufacturing issues that may arise.

* Responsible for identification and resolution of non-conformances via NCR and CAPA process including initiation, root cause analysis and implementation of sustainable corrective action.

* Collaborate with and provide manufacturing input and support to New Product teams, including the design for manufacturing (DFM) guidance, input on process / tooling development and developing/refining manufacturing instructions.

* Collaborate closely with Engineering, R&D, Technical Operations, Quality Assurance and Regulatory teams to ensure proper implementation, sustainability and compliance of manufacturing processes and systems.

* Utilize lean manufacturing principles to improve quality, increase productivity, reduce costs and reduce cycle times.

* Responsible for management of Kanban system for manufacturing components and supplies in close collaborate with Planning, Supply Chain, Quality, Finance and Logistic teams.

* Build and provide leadership for an effective team in a high growth environment including hiring, on-boarding, developing, goal setting and performance improvement in alignment with individual, department and company goals and objectives.

* Evaluate and perform written evaluation of direct report performance on an annual basis. Develop and execute performance improvement plans and disciplinary actions in conjunction with HR, as required.

* Provide technical guidance and input regarding new processing strategies and associated equipment procurement.

* Develop and sustain the manufacturing team as a quality minded culture driven by focusing on customer service (external and internal), outstanding compliance, continuous improvement activities that support business objectives.

* Embody GenMark s cultural beliefs and drive improvements in employee engagement.

Supervisory Responsibilities

30 - 50 non-exempt personnel, additional exempt and/or non-exempt personnel as required

Position Requirements

Education and Experience:

* B.S. degree in Engineering or Science, or AA degree plus 5 years supervisory experience in medical device, pharmaceutical or similarly regulated environment, or High School Diploma plus 7 years supervisory experience in medical device, pharmaceutical or similarly regulated environment

* A minimum of 10 years of manufacturing experience in a medical device, pharmaceutical or similarly regulated environment.

Skills Technical

* Working knowledge of quality system requirements (QSR), good manufacturing practices (GMP), ISO and FDA regulations.

* Experience with a clean room environment including development and implementation of environmental procedures.

* Working knowledge of manufacturing/MRP systems (QAD preferred)

* Experience, training and/or certification in LEAN Manufacturing principles and/or Six Sigma methodologies. Experience with Statistical Process Control a plus.

* Hands-on with a strong sense of urgency, discipline, commitment and organization

Skills General

* Performs both tactically and strategically to provide financial and operational needs to GenMark s business

* Strong time management and organizational skills in a dynamic, constantly changing environment

* Effective interpersonal communication skills with a demonstrated ability to interact with all levels within the organization as well as external customers in a professional manner.

* Hands-on, self-directed, results-driven organized and conscientious

* Completes work in a timely, accurate and thorough manner

* Ability to write, comprehend, edit and analyze complex documents

* Adept at influencing, gaining consensus and overcoming resistance through effective presentation

* Ability to work autonomously, exhibit a professional manner and establish constructive working relationships

* Strong, analytical problem-solving, judgment and decision making skills are required

Certifications, Licenses, Registrations

Work Environment

The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment.

While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.

The work environment and physical demands described are representative of those required by an employee to perform the essential functions of this job with or without reasonable accommodations.

GenMark is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of any kind: GenMark is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at GenMark are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. GenMark will not tolerate discrimination or harassment based on any of these characteristics. GenMark encourages applicants of all ages. GenMark participates in E-Verify. GenMark is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.