Quality Manager 

Are you looking for a great opportunity as Quality Manager in Winston Salem, NC. Then we are looking for you!

Role Summary:

Develop, establish and maintain QA programs, policies, processes and procedures ensuring quality performance or our products.  Ensure all quality documentation i.e. PIR’s, CAR’s, NCR’s, SAR’s are generated and filed as per ISO procedures. Carries out supervisory responsibilities in accordance with company policies and applicable laws.  This job is to be performed in a safe and clean environment.

Key Responsibilities:

  • Supervise the Quality Control personnel, preparing work schedules and assigning specific duties and tasks.
  • Maintain Quality Manual.
  • Revise ISO procedures to confirm to work performed.
  • Assure that all manufacturing process and work orders are performed according to quality standards established.
  • Direct and coordinate quality projects of major magnitude and scope.
  • Provide significant guidance and approval regarding technical strategies and approaches.
  • Assures the adequate implementation of management objectives.
  • Drives the development of department tools and methodologies.
  • Create, maintain, and file all appropriate production documentation to account for material usage and shipments.
  • Develops strategic operational planning, make recommendations for resource allocations and provide key performance indicator (KPI) information to management on product and system performance.  Establishing long-range objectives and specifying the strategies and actions to achieve them (i.e. develop policies, procedures, methods, and/or standards).
  • Supervise and/or perform documentation audits to ensure quality audit compliance.
  • Address customers’ complaints and rejections.
  • Monitor quality products and initiate Corrective Actions if appropriate.  Manages (directly or through subordinates) the functions/task of:  receiving inspection, supplier quality / SCAR, calibration, NCM control, document control, CAPA, internal QMS audit, in-process inspection/SPC, final inspection/release.
  • Communicate goals, objectives, KPI data, quality control metrics, etc. with supervisors, peers, or subordinates through meeting, telephone, in written form, e-mail or in person.
  • Initiate and maintain quality paperwork i.e. PIR’s, CAR’s, SAR’s, NCR’s.
  • Interview and train new employees on Facility rules and procedures, if required.
  • Coach and develop Quality team (one-to-one meeting) – identifying the developmental needs of others and coaching, mentoring, or otherwise assisting/helping others to improve their knowledge, skills, attaining career goals.  Motives individuals to achieve results, and recruits and maintains a high quality team.
  • Perform employee evaluations and recommend merit increases and training requirements.
  • Address and record personnel issues like: attendance, payroll, warnings, vacations and safety issues.
  • Maintain a safe, clean work area at all times.
  • Acts as the management’s representative for Winston Salem
  • Duties include but are not limited to the above. 

The successful candidate will possess the following key attributes:

  • Bachelor’s degree in business or engineering related fields.
  • 5-7 years related experience with a minimum of 2-3 years of supervisory experience.
  • cGMP/cGDP Experience (preferred) or other regulated environment experience (Required)
  • ISO 9001 / ISO 13485
  • Information Analysis (Mini-Tab experience preferred)
  • Quality Engineering (i.e., DOE, Inference Tests, Normality/Capability Analyses, Correlation Studies, Gage RR, etc.)
  • Excellent organizational and oral/written communication skills are required.
  • Strong work ethic.
  • Maintain a positive work atmosphere by behaving and communicating in a manner that fosters a professional environment for clients and associates.
  • Able to interface effectively at all levels and communicate effectivity as part of a team.
  • Strong sense of urgency.
  • Working knowledge of Smartsheet, and Microsoft Office Suite
  • Ability to use measuring equipment i.e., micrometers, calipers is required.
  • Strong analytical skills to make quantitative projections.
  • Ability to apply concepts such as quality engineering statistics, fractions, percentages, ratios, and proportions to practical situations.
  • Must demonstrate effective listening, sound judgement, be well organized, take initiative, be flexible and work well under pressure.

Renumeration Package:

A competitive salary & benefits package is offered based on experience.

We welcome the opportunity to interview candidates who meet the above criteria and who demonstrate initiative, flexibility and the ambition to succeed – please forward CV & cover letter to Ruby Costa, Email: ruby.costa@nelipak.com

Closing date for receipt of applications: February 01 2024