Join our dynamic team in Carlsbad as a leader committed to excellence in manufacturing! As a key member of our organization, you will provide both leadership and technical support to our dedicated manufacturing personnel, ensuring the production of high-quality products that delight our customers. In this pivotal role, you will directly manage a team of skilled production assemblers, oversee the fulfillment of our production schedule, and uphold the highest standards of quality compliance.

Your expertise and technical skills will be instrumental in guiding our manufacturing team to achieve our ambitious goals in New Product Development, Continuous Improvement, Quality, Compliance, and Operational metrics. Your proven track record in operations will empower our team to consistently deliver top-notch results, driving our success and innovation forward.

You will be working on 2nd shift during the hours of 2:00 PM - 10:30 PM (Pacific).

The Opportunity

• Supervise, hire, train, develop, and evaluate production personnel to support manufacturing needs for existing products, new introductions, and R&D builds, ensuring appropriate resources and talent are in place.

• Plan and schedule resources and activities to meet business needs, and track, analyze, summarize, and report key metrics for areas of responsibility.

• Ensure compliance with quality systems (FDA, GMP, QSR, ISO), product specs, process instructions, safety requirements, and company policies, managing non-conformances to implement corrective and preventive actions.

• Identify potential failure modes affecting quality or business risks and collaborate with New Product teams for design for manufacturing (DFM) guidance, process/tooling development, and manufacturing instructions.

• Collaborate with Supply Chain, Logistics, Manufacturing Engineering, and Quality to drive lean manufacturing improvements and provide technical guidance on new processing strategies and equipment procurement.

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

• Identify and implement lean manufacturing opportunities in effort to improve quality, increase productivity, reduce costs and reduce cycle times.

• 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.

Who you are:

• Bachelors degree or Associate's degree and 3 years of supervisory experience in a regulated manufacturing environment. Equivalent combination of education and experience may be considered.

Preferred requirements and skills

Skills 6 Technical

• 2+ years experience in Technical Supervision and/or Engineering in the medical device or pharmaceutical industry.

• Working knowledge of quality system requirements (QSR) and good manufacturing practices (GMP).

• Experience working with a clean room environment, and application of environmental procedures.

• Experience working with manufacturing/MRP systems (QAD preferred)

• Experience and/or certification in LEAN Manufacturing principles.

• Experience and prior training (or ideally certification) with Lean Manufacturing and/or Six Sigma methodologies. Experience with Statistical Process Control a plus.

Skills 6 General

• Must be a hands-on, self-directed, organized and conscientious individual

• Complete work in a timely, accurate and thorough manner

• Must be able to think and work both tactically and strategically to provide financial and operational needs to GenMarks business

• Effective analytical problem solving and decision-making skill

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

• Strong communication skills including the ability to communicate with all levels within the organization

• Ability to read, write and analyze complex documents

• Ability to respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, peers and individuals

• Ability to work effectively, exhibit a professional manner and establish constructive working relationships

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

Supervisory Responsibilities : 20-50 Manufacturing Technicians and other hourly personnel

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 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of California is $61,500- $114,300 Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.