SUMMARY: Supports all QA activities and functions, including ISO 9001 certification and compliance maintenance.

DUTIES AND RESPONSIBILITIES:

QMS/ISO 9001 certification and maintenance

• Oversees, maintains, and updates all QMS and ISO documentation
• Monitors the established QMS objectives and reports findings to the management team.
• Understands the needs of interested parties of the QMS system and keeps the information up to date.
• Establishes and maintains continual improvement of QMS processes and process integration flow.
• Assists in determining risks and opportunities that affect product conformity and assists in managing those risks.
• Point of contact for quality issues and responsible for internal and external communications relating to quality issues.
• Responsible for verifying products and services have successfully met requirements.
• Responsible for QMS internal audit planning and management
• Oversees the QMS nonconformity and corrective action processes

Quality Assurance responsibilities

• Performs and documents internal audits; audits products, complaints, and related systems.
• Prepares audit reports and performs follow-up to obtain resolutions that are compliant with regulations and satisfactory to all parties.
• Identifies in-house quality issues.
• Leads product nonconformance investigations.
• Researches and assists in interpretation of regulations that are relevant to company’s operations.
• Maintains auditing schedules.
• Participates in vendor certification programs, if required
• Maintains quality assurance databases, reports, and files
• Assists in performing audits of external raw material vendors, contractors, collaborators, and other relevant organizations as needed.
• Prepares, performs, and documents personnel training to ensure personnel have the appropriate training and understanding of QA systems.
• Performs timely review of batch production records; assures that records are complete, correct, and meet all pertinent documentation requirements.
• Assists in review of all supporting documentation including but not limited to area and equipment logbooks, cleaning logs, and environmental monitoring data.
• Assists with management reports; analysis of quality-indicating data trends; investigation of deviations, variances, and product complaints; preparation of SOPs, and training manuals or materials as needed.
• Performs other related duties as assigned by management.

QUALIFICATIONS:

· Bachelor’s degree (B.S.) in related field or equivalent experience

· Two to four years related experience or equivalent

· Strong knowledge of manufacturing processes, and product/process validation.

· Ability to develop clear, concise, and timely oral and written reports.

· Proficient PC skills, ERP systems, MS Office suite

· Experience with production environment, equipment and safety procedures.

· Strong organizational, problem-solving, and analytical skills

· Ability to manage priorities and workflow with flexibility in situations of changing priorities. Demonstrated ability to plan and organize projects

· Acute attention to detail

· Proven ability to handle multiple projects and meet deadlines

· Ability to work on complex projects with general direction and minimal guidance.

· Working knowledge of data collection, data analysis, evaluation, and scientific

method.

COMPETENCIES:

• Analytical--Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
• Project Management--Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities.
• Communication--Speaks and writes clearly and informatively; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Presents numerical data effectively.
• Strategic Thinking--Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
• Dependability--Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Completes tasks on time or notifies appropriate person with an alternate plan.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

· Frequently required to walk or stand or sit.

• Frequently required to talk or hear
• Continually utilize visual acuity to operate equipment, read

technical information, and/or use a keyboard

• Occasionally required to lift/push/carry items up to 25 pounds.
• Occasionally exposed to loud noise (examples: metal can manufacturing, large earth-moving equipment)

Job Type: Full-time

Pay: $75,000.00 - $92,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Holidays
• Monday to Friday

Experience:

• ISO 9001: 2 years (Preferred)
• Quality Control: 3 years (Preferred)

Ability to Commute:

• Newark, CA 94560 (Preferred)

Ability to Relocate:

• Newark, CA 94560: Relocate before starting work (Required)

Work Location: In person